x | ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 |
o | TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 |
Delaware | 33-0903395 | |
(State or Other Jurisdiction of Incorporation or Organization) | (I.R.S. Employer Identification No.) | |
2505 Meridian Parkway, Suite 100 Durham, North Carolina | 27713 | |
(Address of Principal Executive Offices) | (Zip Code) |
Title of Each Class | Name of Each Exchange on Which Registered | |
Common Stock, par value $0.001 per share | The NASDAQ Stock Market LLC |
Large accelerated filer o | Accelerated filer x | |
Non-accelerated filer o | Smaller reporting company o | |
(Do not check if a smaller reporting company) | Emerging growth company o |
Document Description Portions of the registrant’s notice of annual meeting of stockholders and proxy statement to be filed pursuant to Regulation 14A within 120 days after registrant’s fiscal year end of December 31, 2017 are incorporated by reference into Part III of this report……………………………………………………… | 10-K Part III |
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• | the initiation, cost, timing, progress and results of our research and development activities, preclinical studies and future clinical trials; |
• | our ability to obtain and maintain regulatory approval of our current and future product candidates, and any related restrictions, limitations, and/or warnings in the label of an approved product candidate; |
• | our ability to obtain funding for our operations; |
• | our plans to research, develop and commercialize our future product candidates; |
• | our strategic alliance partners’ election to pursue development and commercialization; |
• | our ability to attract collaborators with development, regulatory and commercialization expertise; |
• | our ability to obtain and maintain intellectual property protection for our future product candidates; |
• | the size and growth potential of the markets for our current and future product candidates, and our ability to serve those markets; |
• | our ability to successfully commercialize our current and future product candidates; |
• | the rate and degree of market acceptance of our current and future product candidates; |
• | our ability to develop sales and marketing capabilities, whether alone or with potential future collaborators; |
• | regulatory developments in the United States and foreign countries; |
• | the performance of our third-party suppliers and manufacturers; |
• | the success of competing therapies that are or become available; |
• | the loss of key scientific or management personnel; |
• | our use of the proceeds from our public offerings; and |
• | the accuracy of our estimates regarding expenses, future revenues, capital requirements and need for additional financing. |
I. | Oral Formulations of Brincidofovir |
A. | Oral Brincidofovir for Treatment of AdV |
B. | Oral Brincidofovir for Treatment of Smallpox |
C. | Oral Brincidofovir Expanded Access Program |
II. | IV Formulation of Brincidofovir |
A. | IV Brincidofovir Multiple Ascending Dose Study in Healthy Subjects |
B. | Phase 2 Studies Planned to Initiate in 1H2018 |
• | Advance Oral and IV Formulations of Brincidofovir for the Prevention and Treatment of Serious DNA Virus Infections. We are conducting AdAPT, a small comparative clinical trial designed to study the effect of brincidofovir versus SOC in pediatric patients with AdV infection following allogeneic HCT. This study will be conducted at sites in the United States and Europe. If successful, AdAPT may form the basis of an application for conditional or full marketing approval of brincidofovir in the EU for the treatment of AdV infection in HCT recipients. A successful trial may also further support potential continued development of oral brincidofovir in the U.S. Assuming the trial is fully enrolled by the first half of 2019, we expect to receive data from the trial in the second half of 2019 with the potential for an EU approval in 2020. |
• | Progress Development of Brincidofovir as a Medical Countermeasure for the Treatment of Smallpox. We have conducted efficacy studies under the FDA’s Animal Rule to demonstrate the impact of immediate or delayed brincidofovir in a well-characterized model of smallpox infection. We are working with the FDA and BARDA on the development of our second, adjunct rabbitpox study as well as a second animal model, mousepox. We plan to submit an NDA to the FDA, contingent upon the results of the animal efficacy studies we intend to conduct during 2018. In addition, we received advice from the EMA on the development plan for smallpox, in which the submission of a marketing application with data from completed studies, including our earlier completed large rabbitpox efficacy study, was discussed. This study in combination with supportive mousepox study data was considered sufficient for review by EMA. We are in the process of preparing for a marketing application submission to EMA in early 2019. |
• | Develop CMX521 for the Prevention and Treatment of Norovirus. We are currently conducting a first-time-in-human study of CMX521. This Phase 1 study is evaluating the pharmacokinetics, safety and tolerability of CMX521 in up to 50 adult subjects. The study also includes the collection of gut biopsy specimens, which will allow for the determination of active drug concentrations in the target gut tissue. Study results are expected in mid-2018. |
• | Discover and Develop Additional Product Candidates to Strengthen our Product Portfolio. We have an active discovery and preclinical development program focused on identifying and developing new compounds that can be used to treat diseases for which no current therapeutic option exists or which otherwise continue to have high unmet medical need. We intend to leverage our knowledge and experience of nucleoside analogs to advance compounds in the Chimerix Chemical Library through IND-enabling studies and potential clinical development and/or |
• | Evaluate external opportunities to strengthen our pipeline. We are looking at business development opportunities as a means to complement our existing pipeline with technologies that will take advantage of our strengths. We are actively seeking opportunities to grow our business through the acquisition of or investment in other companies, through strategic relationships, or through in-licensing of complementary compounds and products. |
• | Vistide® (cidofovir for injection), marketed by Gilead Sciences, Inc. and generic manufacturers; and |
• | patient-specific T-cell therapies. |
• | letermovir (marketed under the trade name PREVYMIS), an anti-CMV drug recently approved for the prevention of CMV infections in adult HCT recipients pursuant to an exclusive worldwide license agreement between AiCuris GmbH & Co. KG and Merck & Co., Inc.; |
• | maribavir, an antiviral owned by Shire plc, currently in Phase 3 trials for the treatment of CMV resistant or refractory CMV infections in both HCT and SOT adult patients, and for preemptive use in adult HCT patients; and |
• | patient-specific T-cell therapies directed at antigens of CMV and other dsDNA viruses. |
• | 146 patents or patent applications that we own or have in-licensed from academic institutions, related to brincidofovir and CMX157, which represented a slight increase over the number of patents in our patent portfolio at the end of fiscal 2016; |
• | This includes 96 US and foreign exclusively and jointly owned patents and 50 US and foreign applications related to brincidofovir and CMX157. Granted European patents are counted as one patent and have been validated throughout Europe; |
• | 20 jointly-owned patents or patent applications related to our agreement with the UM regarding our proprietary Chemical Library; and |
• | One US provisional patent application owned exclusively by Chimerix directed to a morphic form of a compound from the Chemical Library. |
• | completion of nonclinical laboratory tests, animal studies and formulation studies according to good laboratory practices (GLP), or other applicable regulations; |
• | submission to the FDA of an application for an IND, which must become effective before human clinical trials may begin; |
• | performance of adequate and well-controlled human clinical trials according to the FDA’s regulations commonly referred to as current good clinical practices (GCPs), to establish the safety and efficacy of the proposed drug for its intended use; |
• | submission to the FDA of a NDA for a new drug; |
• | satisfactory completion of an FDA inspection of the manufacturing facility or facilities where the drug is produced to assess compliance with the FDA’s current good manufacturing practice standards (cGMP), to assure that the facilities, methods and controls are adequate to preserve the drug’s identity, strength, quality and purity; |
• | potential FDA inspection of the nonclinical and clinical trial sites that generated the data in support of the NDA; and FDA review of the NDA. |
• | Phase 1. The drug is initially introduced into healthy human subjects and tested for safety, dosage tolerance, absorption, metabolism, distribution and excretion. In the case of some products for severe or life-threatening diseases, especially when the product may be too inherently toxic to ethically administer to healthy volunteers, the initial human testing is often conducted in patients. |
• | Phase 2. The drug is evaluated in a limited patient population to identify possible adverse effects and safety risks, to preliminarily evaluate the efficacy of the product for specific targeted diseases and to determine dosage tolerance, optimal dosage and dosing schedule. |
• | Phase 3. Clinical trials are undertaken to further evaluate dosage, clinical efficacy and safety in an expanded patient population at geographically dispersed clinical trial sites. These clinical trials are intended to establish the overall risk/benefit ratio of the product and provide an adequate basis for product labeling. Generally, two adequate and well-controlled Phase 3 clinical trials are required by the FDA for approval of an NDA. |
• | aimed at treating, preventing or diagnosing seriously debilitating or life-threatening diseases; |
• | intended for use in emergency situations (also less comprehensive pharmaceutical and non-clinical data may be accepted for such products); and/or |
• | designated as orphan medicines. |
• | it must be intended for the treatment, prevention or diagnosis of a disease that is life-threatening or chronically debilitating; |
• | the prevalence of the condition in the EU must not be more than 5 in 10,000 or it must be unlikely that marketing of the medicine would generate sufficient returns to justify the investment needed for its development; and |
• | no satisfactory method of diagnosis, prevention or treatment of the condition concerned can be authorized, or, if such a method exists, the medicine must be of significant benefit to those affected by the condition. |
• | continue the development of our lead product candidate, brincidofovir, for the treatment of AdV infection; |
• | advance the development of an IV formulation of brincidofovir; |
• | continue the development of brincidofovir for the prevention or treatment of CMV, AdV, BK virus, and other viral indications in HCT recipients, solid organ transplant recipients and other patient populations; |
• | continue the development of brincidofovir for the treatment of smallpox as a medical countermeasure; |
• | obtain regulatory approvals for brincidofovir; |
• | scale-up manufacturing capabilities to commercialize brincidofovir for any indications for which we receive regulatory approval; |
• | advance the development of CMX521 for norovirus; |
• | expand our research and development activities and advance our clinical programs; |
• | maintain, expand and protect our intellectual property portfolio; |
• | continue our research and development efforts and seek to discover additional product candidates; and |
• | add operational, financial and management information systems and personnel, including personnel to support our product development and commercialization efforts and operations as a public company. |
• | obtaining favorable results for and advancing the development of brincidofovir and our other product candidates, including successfully completing clinical development of IV and oral formulations of brincidofovir; |
• | obtaining United States and foreign regulatory approval(s) for brincidofovir; |
• | launching and commercializing brincidofovir, including establishing a sales force and/or collaborating with third party providers of sales organizations; |
• | achieving broad market acceptance of brincidofovir in the medical community and with third-party payers; |
• | delivering a competitive value proposition compared to established competition and/or competitors who will enter the market before or after any of our product candidates, including brincidofovir; and |
• | generating, licensing or otherwise acquiring a pipeline of product candidates which progress to clinical development, regulatory approval, and commercialization. |
• | significantly delay, scale back or discontinue the development or commercialization of our product candidates, including brincidofovir; |
• | seek corporate partners for brincidofovir or any of our other product candidates at an earlier stage than otherwise would be desirable or on terms that are less favorable than might otherwise be available; or |
• | relinquish or license on unfavorable terms, our rights to technologies or product candidates that we otherwise would seek to develop or commercialize ourselves. |
• | successful conduct of required trial(s) of oral brincidofovir for the treatment of adenovirus; |
• | successful conduct of a second efficacy study of oral brincidofovir in an animal model of smallpox infection, and acceptance of data from these animal model studies by the FDA and foreign regulatory bodies; |
• | development of an IV formulation and/or alternate drug formulations; |
• | receipt of marketing approvals from the FDA and corresponding regulatory authorities outside the United States; |
• | establishing commercial manufacturing capabilities; |
• | launching commercial sales of the product, whether alone or in collaboration with others; |
• | acceptance of the product by patients, the medical community and third-party payers; |
• | effectively competing with other therapies; |
• | a continued acceptable safety profile of the product following approval; |
• | obtaining, maintaining, enforcing and defending intellectual property rights and claims; and |
• | establishing distribution channels in the EU and U.S. |
• | regulators or institutional review boards may not authorize us or our investigators to commence a clinical trial or conduct a clinical trial at a prospective trial site; |
• | clinical trials of our product candidates may produce negative or inconclusive results, and we may decide, or regulators may require us, to conduct additional clinical trials or abandon product development programs; |
• | animal efficacy studies of our product candidates may produce negative or inconclusive results, and we may decide, or regulators may require us to conduct additional animal efficacy studies or abandon development programs; |
• | we might be required to change one of our clinical research organizations (CROs) during ongoing clinical programs; |
• | the number of subjects required for clinical trials of our product candidates may be larger than we anticipate, enrollment in these clinical trials may be insufficient or slower than we anticipate or subjects may drop out of these clinical trials at a higher rate than we anticipate; |
• | our third-party contractors may fail to comply with regulatory requirements or meet their contractual obligations to us in a timely manner, or at all; |
• | we may have to suspend or terminate clinical trials of our product candidates for various reasons, including a finding that the subjects are being exposed to unacceptable health risks; |
• | regulators or institutional review boards may require that we or our investigators suspend or terminate clinical research for various reasons, including noncompliance with regulatory requirements; |
• | the cost of clinical trials of our product candidates may be greater than we anticipate; |
• | we may encounter agency or judicial enforcement actions which impact our clinical trials; |
• | the supply or quality of our product candidates or other materials necessary to conduct clinical trials of our product candidates may be insufficient or inadequate; or |
• | our product candidates may have undesirable side effects or other unexpected characteristics, causing us or our investigators to suspend or terminate the trials. |
• | inability to raise funding necessary to initiate or continue a trial; |
• | delays in obtaining, or failure to obtain, regulatory approval of Investigational New Drug applications or to commence a trial; |
• | delays in reaching agreement with the FDA and foreign health authorities on final trial design; |
• | imposition of a clinical hold following an inspection of our clinical trial operations or trial sites by the FDA or other regulatory authorities; |
• | delays caused by disagreements with existing CROs and/or clinical trial sites; |
• | delays in reaching agreement on acceptable terms with prospective CROs and clinical trial sites; |
• | delays in obtaining, or failure to obtain, required IRB or ethics committee (EC) approvals covering each site; |
• | delays in recruiting suitable patients to participate in a trial; |
• | delays in having subjects complete participation in a trial or return for post-treatment follow-up; |
• | delays caused by subjects dropping out of a trial due to side effects or otherwise; |
• | clinical sites declining to participate or dropping out of a trial to the detriment of enrollment; |
• | agency or judicial enforcement actions against us; |
• | time required to add new clinical sites; and |
• | delays by our contract manufacturers to produce and deliver sufficient supply of clinical trial materials. |
• | regulatory authorities may approve the product only with a REMS, potentially with restrictions on distribution and other elements to assure safe use (ETASU); |
• | regulatory authorities may withdraw their approval of the product or impose restrictions on its distribution in a form of a modified REMS; |
• | regulatory authorities may require the addition of labeling statements, such as warnings or contraindications; |
• | we may be required to change the way the product is administered or to conduct additional clinical studies; |
• | we could be sued and held liable for harm caused to patients; and |
• | our reputation may suffer. |
• | issue an untitled or warning letter asserting that we are in violation of the law; |
• | seek an injunction or impose civil or criminal penalties or monetary fines; |
• | suspend or withdraw regulatory approval; |
• | suspend any ongoing clinical trials; |
• | refuse to approve a pending application or supplements to an application submitted by us; |
• | recall and/or seize product; or |
• | refuse to allow us to enter into supply contracts, including government contracts. |
• | the federal healthcare anti-kickback statute which prohibits, among other things, persons or entities from knowingly and willfully soliciting, offering, receiving or paying remuneration (including any kickback, bribe or rebate), directly or indirectly, overtly or covertly, in cash or in kind, to induce or reward either the referral of an individual for, or the purchase, lease, order or recommendation of, any good, facility, item or service, for which payment may be made, in whole or in part, under federal healthcare programs such as Medicare and Medicaid; |
• | the federal civil and criminal false claims laws and civil monetary penalties, including civil whistleblower or qui tam actions, which prohibit, among other things, individuals or entities from knowingly presenting, or causing to be presented, to the federal government, claims for payment or approval that are false or fraudulent or from knowingly making a false statement to improperly avoid, decrease or conceal an obligation to pay money to the federal government; |
• | the federal Health Insurance Portability and Accountability Act of 1996 (HIPAA) which, among other things, imposes criminal liability for knowingly and willfully executing, or attempting to execute, a scheme to defraud any healthcare benefit program or to obtain, by means of false or fraudulent pretenses, representations, or promises, any of the money or property owned by, or under the custody or control of, any healthcare benefit program, regardless of the payer (e.g., public or private) and knowingly or willfully falsifying, concealing or covering up by any trick or device a material fact or making any materially false statement in connection with the delivery of, or payment for, healthcare benefits, items or services relating to healthcare matters; |
• | HIPAA, as amended by the Health Information Technology for Economic and Clinical Health Act (HITECH) and its implementing regulations, and as amended again by the final HIPAA omnibus rule, Modifications to the HIPAA Privacy, Security, Enforcement, and Breach Notification Rules Under HITECH and the Genetic Information Nondiscrimination Act; Other Modifications to HIPAA, published in January 2013, which imposes certain obligations, including mandatory contractual terms, with respect to safeguarding the privacy, security and transmission of individually identifiable health information without appropriate authorization by entities subject to the rule, such as health plans, clearinghouses and certain healthcare providers, as well as their business associates; |
• | the EU Data Privacy Directive, along with any related national legislation, and the General Data Protection Regulation (GDPR), which all impose obligations on companies in relation to the handling of personal data of individuals within the EU; |
• | mandated physician payments reporting laws and/or requirements throughout global jurisdictions, including EU member states, in which we conduct research and development and/or other business activities; |
• | the FDCA which prohibits, among other things, the adulteration or misbranding of drugs and devices; |
• | the federal transparency law, enacted as part of the Patient Protection and Affordable Care Act and Health Care and Education Reconciliation Act of 2010 (collectively, the ACA), and its implementing regulations, which requires manufacturers of drugs, devices, biologicals and medical supplies to report to the U.S. Department of Health and Human Services information related to payments and other transfers of value made to physicians and teaching hospitals, as well as ownership and investment interests held by physicians and their immediate family members; and |
• | analogous state laws and regulations, including: state anti-kickback and false claims laws, which may apply to our business practices, including but not limited to, research, distribution, sales and marketing arrangements and claims involving healthcare items or services reimbursed by state governmental and non-governmental third-party payers, including private insurers; state laws that require pharmaceutical companies to comply with the pharmaceutical industry’s voluntary compliance guidelines and the relevant compliance guidance promulgated by the federal government; and state laws and regulations that require manufacturers to file reports relating to pricing and marketing information, which requires tracking gifts and other remuneration and items of value provided to healthcare professionals and entities. |
• | inability to meet our product specifications and quality requirements consistently; |
• | delay or inability to procure or expand sufficient manufacturing capacity; |
• | manufacturing and product quality issues related to scale-up of manufacturing; |
• | costs and validation of new equipment and facilities required for scale-up; |
• | failure to comply with cGMP and similar foreign standards; |
• | inability to negotiate manufacturing agreements with third parties under commercially reasonable terms; |
• | termination or nonrenewal of manufacturing agreements with third parties in a manner or at a time that is costly or damaging to us; |
• | reliance on a limited number of sources, and in some cases, single sources for product components, such that if we are unable to secure a sufficient supply of these product components, we will be unable to manufacture and sell our product candidates in a timely fashion, in sufficient quantities or under acceptable terms; |
• | lack of qualified backup suppliers for those components that are currently purchased from a sole or single source supplier; |
• | operations of our third-party manufacturers or suppliers could be disrupted by conditions unrelated to our business or operations, including the bankruptcy of the manufacturer or supplier; |
• | carrier disruptions or increased costs that are beyond our control; and |
• | failure to deliver our products under specified storage conditions and in a timely manner. |
• | lacks or does not devote sufficient time and resources to the development and commercialization of CMX157; |
• | lacks or does not devote sufficient capital to fund the development and commercialization of CMX157; |
• | develops, either alone or with others, products that compete with CMX157; |
• | fails to gain the requisite regulatory approvals for CMX157; |
• | does not successfully commercialize CMX157; |
• | does not conduct its activities in a timely manner; |
• | terminates its license with us; |
• | does not effectively pursue and enforce intellectual property rights relating to CMX157; or |
• | merges with a third-party that wants to terminate the collaboration. |
• | demonstration of clinical safety and efficacy in our clinical trials; |
• | relative convenience, ease of administration and acceptance by physicians, patients, pharmacists and health care payers; |
• | prevalence and severity of any AEs; |
• | limitations or warnings contained in the FDA-approved labeling from Regulatory Authorities such as the FDA and EMA for the relevant product candidate; |
• | availability, efficacy and safety of alternative treatments; |
• | price and cost-effectiveness; |
• | effectiveness of our or any future collaborators’ or competitor’s sales and marketing strategies; |
• | ability to obtain hospital formulary approval; |
• | ability to ensure availability for product through appropriate channels; |
• | ability to maintain adequate inventory; and |
• | ability to obtain and maintain sufficient third-party coverage and reimbursement, which may vary from country to country. |
• | recruiting and retaining talented people; |
• | training employees that we recruit; |
• | establishing compliance standards; |
• | setting the appropriate system of incentives; |
• | managing additional headcount; |
• | ensuring that appropriate support functions are in place to support sales force organizational needs; and |
• | integrating a new business unit into an existing corporate architecture. |
• | different regulatory requirements for drug approvals in the EU and other foreign countries; |
• | reduced protection for intellectual property rights; |
• | unexpected changes in tariffs, trade barriers and regulatory and labor requirements; |
• | economic weakness, including inflation, or political instability in particular foreign economies and markets; |
• | compliance with tax, employment, immigration and labor laws for employees living or traveling abroad; |
• | foreign taxes, including withholding of payroll taxes; |
• | foreign currency fluctuations, which could result in increased operating expenses and reduced revenues, and other obligations incident to doing business in another country; |
• | workforce uncertainty in countries where labor unrest is more common than in the United States; |
• | production shortages resulting from any events affecting raw material supply or manufacturing capabilities abroad; |
• | business interruptions resulting from geopolitical actions, including war and terrorism, or natural disasters including earthquakes, typhoons, floods and fires; and |
• | regulatory and compliance risks that relate to maintaining accurate information and control over activities that may fall within the purview of the U.S. Foreign Corrupt Practices Act, its books and records provisions or its anti‑bribery provisions, or similar anti‑bribery or anti‑corruption laws and regulations. |
• | Vistide® (cidofovir for injection), marketed by Gilead Sciences, Inc. and generic manufacturers; |
• | oral and intravenous ganciclovir, a drug that is sold by generic manufacturers; |
• | Valcyte® (valganciclovir), a prodrug of ganciclovir that is marketed by Genentech, Inc. and generic manufacturers; |
• | foscarnet sodium for injection available through generic manufacturers; |
• | acyclovir, a drug that is sold by generic manufacturers; |
• | letermovir (marketed under the trade name PREVYMIS), an anti-CMV drug being developed pursuant to an exclusive worldwide license agreement between AiCuris GmbH & Co. KG and Merck & Co., Inc.; and |
• | investigational patient-specific T-cell therapies. |
• | maribavir (SHP620) from Shire for CMV infections in transplant recipients; and |
• | patient-specific T-cell therapies directed at antigens of CMV and other DNA viruses, including AdV. |
• | discover and develop medicines that are superior to other products in the market; |
• | demonstrate through our clinical trials that our product candidates, including brincidofovir, are differentiated from existing and future therapies; |
• | evaluate new potential indications across the lifecycle of brincidofovir; |
• | attract qualified scientific, product development and commercial personnel; |
• | obtain and successfully defend and enforce patent and/or other proprietary protection for our medicines and technologies; |
• | obtain required regulatory approvals; |
• | successfully collaborate with pharmaceutical companies in the discovery, development and commercialization of new medicines; |
• | deliver a competitive value proposition compared to established competition and/or competitors who will enter the market before or after any of our product candidates, including brincidofovir; and |
• | negotiate competitive pricing and reimbursement with third-party payers. |
• | our research methodology or that of our collaboration partners may be unsuccessful in identifying potential product candidates; |
• | our potential product candidates may be shown to have harmful side effects or may have other characteristics that may make the products unmarketable or unlikely to receive marketing approval; and |
• | our collaboration partners may change their development profiles for potential product candidates or abandon a therapeutic area. |
• | audit and object to any BARDA contract-related costs and fees on grounds that they are not allowable under the FAR, and require us to reimburse all such costs and fees; |
• | suspend or prevent us for a set period of time from receiving new contracts or extending our existing contract based on violations or suspected violations of laws or regulations; |
• | claim nonexclusive, nontransferable rights to product manufactured and intellectual property developed under the BARDA contract and may, under certain circumstances, such as circumstances involving public health and safety, license such inventions to third parties without our consent; |
• | cancel, terminate or suspend our BARDA contract based on violations or suspected violations of laws or regulations; |
• | terminate our BARDA contract in whole or in part for the convenience of the government for any reason or no reason, including if funds become unavailable to the applicable governmental agency; |
• | reduce the scope and value of our BARDA contract; |
• | decline to exercise an option to continue the BARDA contract; |
• | direct the course of a development program in a manner not chosen by the government contractor; |
• | require us to perform the option segments even if doing so may cause us to forego or delay the pursuit of other opportunities with greater commercial potential; |
• | take actions that result in a longer development timeline than expected; and |
• | change certain terms and conditions in our BARDA contract. |
• | FAR, and agency-specific regulations supplements to the FAR, which comprehensively regulate the procurement, formation, administration and performance of government contracts and implement federal procurement policy in numerous areas, such as employment practices, protection of the environment, accuracy and retention periods of records, recording and charging of costs, treatment of laboratory animals and human subject research; |
• | business ethics and public integrity obligations, which govern conflicts of interest and the hiring of former government employees, restrict the granting of gratuities and funding of lobbying activities and incorporate other requirements such as the Anti-Kickback Act and the Foreign Corrupt Practices Act; |
• | export and import control laws and regulations; and |
• | laws, regulations and executive orders restricting the use and dissemination of information classified for national security purposes and the exportation of certain products and technical data. |
• | termination of contracts; |
• | forfeiture of profits; |
• | suspension of payments; |
• | fines; and |
• | suspension or prohibition from conducting business with the U.S. government. |
• | impairment of our business reputation and significant negative media attention; |
• | withdrawal of participants from our clinical studies; |
• | significant costs to defend the related litigation and related litigation; |
• | distraction of management’s attention from our primary business; |
• | substantial monetary awards to patients or other claimants; |
• | inability to commercialize our product candidates, including brincidofovir; and |
• | decreased demand for our product candidates, if approved for commercial sale. |
• | multiple, conflicting and changing laws and regulations such as tax laws, privacy regulations, export and import restrictions, employment, immigration and labor laws, regulatory requirements, and other governmental approvals, permits and licenses; |
• | difficulties in staffing and managing foreign operations; |
• | risks associated with obtaining and maintaining, or the failure to obtain or maintain, regulatory approvals for the sale or use of our products in various countries; |
• | complexities associated with managing government payer systems, multiple payer-reimbursement regimes or patient self-pay systems; |
• | financial risks, such as longer payment cycles, difficulty enforcing contracts and collecting accounts receivable and exposure to foreign currency exchange rate fluctuations; |
• | general political and economic conditions in the countries in operate, including terrorism and political unrest, curtailment of trade and other business restrictions; |
• | regulatory and compliance risks that relate to maintaining accurate information and control over activities that may fall within the purview of the U.S. Foreign Corrupt Practices Act, its books and records provisions or its anti-bribery provisions, or similar anti-bribery or anti-corruption laws and regulations. |
• | results of clinical trials of our product candidates or those of our competitors; |
• | any delay in filing an application for any of our product candidates and any adverse development or perceived adverse development with respect to regulatory review of that application; |
• | failure to successfully develop and commercialize our product candidates, including brincidofovir; |
• | termination of any of our license or collaboration agreements; |
• | any agency or judicial enforcement actions against us; |
• | inability to obtain additional funding; |
• | regulatory or legal developments in the United States and other countries applicable to our product candidates; |
• | adverse regulatory decisions; |
• | changes in the structure of healthcare payment systems; |
• | inability to obtain adequate product supply for our product candidates, or the inability to do so at acceptable prices; |
• | introduction of new products, services or technologies by our competitors; |
• | failure to meet or exceed financial projections we provide to the public; |
• | failure to meet or exceed the estimates and projections of the investment community; |
• | changes in the market valuations of similar companies; |
• | market conditions in the pharmaceutical and biotechnology sectors, and the issuance of new or changed securities analysts’ reports or recommendations; |
• | announcements of significant acquisitions, strategic partnerships, joint ventures or capital commitments by us or our competitors; |
• | significant lawsuits (including patent or stockholder litigation), and disputes or other developments relating to proprietary rights (including patents, litigation matters and our ability to obtain patent protection for our technologies); |
• | additions or departures of key scientific or management personnel; |
• | sales of our common stock by us or our stockholders in the future; |
• | trading volume of our common stock; |
• | general economic, industry and market conditions; and |
• | the other factors described in this “Risk Factors” section. |
• | authorizing the issuance of “blank check” preferred stock, the terms of which may be established and shares of which may be issued without stockholder approval which could be used to institute a “poison pill” that would work to dilute the stock ownership of a potential hostile acquirer, effectively preventing acquisitions that have not been approved by our board of directors; |
• | allowing the authorized number of our directors to be changed only by resolution of our board of directors; |
• | limiting the removal of directors; |
• | creating a staggered board of directors; |
• | requiring that stockholder actions must be effected at a duly called stockholder meeting and prohibiting stockholder actions by written consent; |
• | eliminating the ability of stockholders to call a special meeting of stockholders; and |
• | establishing advance notice requirements for nominations for election to the board of directors or for proposing matters that can be acted upon at duly called stockholder meetings. |
Year Ended December 31, 2017 | |||||||
High | Low | ||||||
First Quarter | $ | 6.64 | $ | 4.33 | |||
Second Quarter | $ | 6.57 | $ | 4.28 | |||
Third Quarter | $ | 5.60 | $ | 4.30 | |||
Fourth Quarter | $ | 5.54 | $ | 4.17 | |||
Year Ended December 31, 2016 | |||||||
High | Low | ||||||
First Quarter | $ | 9.72 | $ | 4.36 | |||
Second Quarter | $ | 6.47 | $ | 3.50 | |||
Third Quarter | $ | 5.96 | $ | 3.71 | |||
Fourth Quarter | $ | 5.64 | $ | 3.66 |
Years Ended December 31, | |||||||||||||||||||
Consolidated Statement of Operations and Comprehensive Loss Data | 2017 | 2016 | 2015 | 2014 | 2013 | ||||||||||||||
Revenues: | |||||||||||||||||||
Contract revenue | $ | 4,494 | $ | 5,702 | $ | 9,214 | $ | 4,040 | $ | 4,370 | |||||||||
Collaboration and licensing revenue | — | — | 1,548 | — | — | ||||||||||||||
Total revenues | 4,494 | 5,702 | 10,762 | 4,040 | 4,370 | ||||||||||||||
Operating expenses: | |||||||||||||||||||
Research and development | 49,448 | 58,647 | 97,717 | 45,379 | 24,662 | ||||||||||||||
General and administrative | 27,148 | 25,007 | 31,296 | 17,527 | 8,327 | ||||||||||||||
Total operating expenses | 76,596 | 83,654 | 129,013 | 62,906 | 32,989 | ||||||||||||||
Loss from operations | (72,102 | ) | (77,952 | ) | (118,251 | ) | (58,866 | ) | (28,619 | ) | |||||||||
Other (expense) income: | |||||||||||||||||||
Other-than-temporary impairment of investment | (1,160 | ) | — | — | — | — | |||||||||||||
Interest income (expense), net | 2,278 | 1,562 | 879 | (446 | ) | (1,236 | ) | ||||||||||||
Fair value adjustments to preferred stock warrant liability | — | — | — | — | (6,590 | ) | |||||||||||||
Net loss | (70,984 | ) | (76,390 | ) | (117,372 | ) | (59,312 | ) | (36,445 | ) | |||||||||
Accretion of redeemable convertible preferred stock | — | — | — | — | (34,108 | ) | |||||||||||||
Net loss attributable to common shareholders | $ | (70,984 | ) | $ | (76,390 | ) | $ | (117,372 | ) | $ | (59,312 | ) | $ | (70,553 | ) | ||||
Net loss per share, basic and diluted | $ | (1.51 | ) | $ | (1.65 | ) | $ | (2.67 | ) | $ | (1.80 | ) | $ | (3.65 | ) | ||||
Weighted-average shares outstanding, basic and diluted | 46,963,430 | 46,267,064 | 43,878,326 | 33,003,714 | 19,307,422 |
Years Ended December 31, | |||||||||||||||||||
Consolidated Balance Sheet Data | 2017 | 2016 | 2015 | 2014 | 2013 | ||||||||||||||
Cash and cash equivalents | $ | 18,548 | $ | 51,463 | $ | 20,605 | $ | 128,462 | $ | 109,976 | |||||||||
Short-term investments, available-for-sale (1) | 132,972 | 180,558 | 199,729 | 106,114 | — | ||||||||||||||
Working capital | 143,337 | 226,360 | 208,658 | 220,390 | 102,802 | ||||||||||||||
Long-term investments (1) | 76,731 | 47,407 | 124,040 | 52,973 | — | ||||||||||||||
Total assets | 235,230 | 286,770 | 355,992 | 291,878 | 113,387 | ||||||||||||||
Loan payable, net, current portion (2) | — | — | — | 4,296 | 5,573 | ||||||||||||||
Loan payable, net, less current portion (2) | — | — | — | — | 4,294 | ||||||||||||||
Accumulated deficit | (486,788 | ) | (415,804 | ) | (339,414 | ) | (222,042 | ) | (162,730 | ) | |||||||||
Total stockholders’ equity (deficit) | $ | 221,810 | $ | 276,224 | $ | 335,459 | $ | 274,636 | $ | 98,539 |
(1) | Further details of investments is available in "Notes to Consolidated Financial Statements, Note 1. Fair Value of Financial Instruments" in Item 8 of this Annual Report. |
• | fees paid to consultants and contract research organizations (CROs), including in connection with our preclinical and clinical trials, and other related clinical trial fees, such as for investigator grants, patient screening, laboratory work, clinical trial database management, clinical trial material management and statistical compilation and analysis; |
• | salaries and related overhead expenses, which include stock option, restricted stock unit (RSU) and employee stock purchase program compensation and benefits, for personnel in research and development functions; |
• | payments to third-party manufacturers, which produce, test and package our drug substance and drug product (including continued testing of process validation and stability); |
• | costs related to legal and compliance with regulatory requirements; and |
• | license fees for and milestone payments related to licensed products and technologies. |
Years Ended December 31, | |||||||||||
2017 | 2016 | 2015 | |||||||||
Direct research and development expenses | $ | 24,734 | $ | 31,415 | $ | 70,348 | |||||
Research and development personnel costs - excluding stock-based compensation | 13,490 | 15,035 | 16,691 | ||||||||
Research and development personnel costs - stock-based compensation | 7,047 | 7,137 | 5,578 | ||||||||
Indirect research and development expenses | 4,177 | 5,060 | 5,100 | ||||||||
Total research and development expenses | $ | 49,448 | $ | 58,647 | $ | 97,717 |
• | the uncertainty of the scope, rate of progress and expense of our ongoing, as well as any additional, clinical trials and other research and development activities; |
• | the potential benefits of our candidates over other therapies; |
• | the ability to market, commercialize and achieve market acceptance for any of our product candidates that we are developing or may develop in the future; |
• | the results of ongoing or future clinical trials; |
• | the timing and receipt of any regulatory approvals; and |
• | the filing, prosecuting, defending and enforcing of patent claims and other intellectual property rights, and the expense of doing so. |
Years Ended December 31, | |||||||||||
2017 | 2016 | 2015 | |||||||||
Income Statement Classification: | |||||||||||
Research and development expense | $ | 7,047 | $ | 7,137 | $ | 5,578 | |||||
General and administrative expense | 9,063 | 9,086 | 7,381 | ||||||||
Total stock-based compensation expense | $ | 16,110 | $ | 16,223 | $ | 12,959 |
• | We have limited operating history to estimate the volatility of our common stock price. We calculate expected volatility based on a blend of company specific historical data and a group of similar publicly traded companies for which the historical information is available. For the purpose of identifying peer companies, we consider characteristics such as industry, length of trading history, similar vesting terms and in-the-money option status. We plan to continue to use the guideline peer group volatility information until the historical volatility of our common stock is relevant to measure expected volatility for future option grants. |
• | We use historical exercise data to estimate expected term. |
• | We determine the risk-free interest rate by reference to implied yields available from U.S. Treasury securities with a remaining term equal to the expected life assumed at the date of grant. |
• | The assumed dividend yield is based on our expectation of not paying dividends for the foreseeable future. |
• | We estimate forfeitures based on our historical analysis of actual stock option forfeitures. |
Years Ended December 31, | |||||||||||
2017 | 2016 | 2015 | |||||||||
Expected volatility | 85.51 | % | 85.16 | % | 66.89 | % | |||||
Expected term (in years) | 5.9 | 6.0 | 6.0 | ||||||||
Weighted-average risk-free interest rate | 2.02 | % | 1.70 | % | 1.53 | % | |||||
Expected dividend yield | — | % | — | % | — | % | |||||
Weighted-average fair value per option | $ | 3.71 | $ | 5.62 | $ | 25.18 |
Years Ended December 31, | |||||||||||
2017 | 2016 | 2015 | |||||||||
Expected volatility | 77.18 | % | 111.57 | % | 57.77 | % | |||||
Expected term (in years) | 0.97 | 1.37 | 1.15 | ||||||||
Weighted-average risk-free interest rate | 0.99 | % | 0.75 | % | 0.43 | % | |||||
Expected dividend yield | — | % | — | % | — | % | |||||
Weighted-average option value per share | $ | 2.65 | $ | 3.20 | $ | 22.10 |
Years Ended December 31, | Dollar Change | % Change | ||||||||||||
2017 | 2016 | Increase/(Decrease) | ||||||||||||
Contract revenue | $ | 4,494 | $ | 5,702 | $ | (1,208 | ) | (21.2 | )% | |||||
Operating expenses: | ||||||||||||||
Research and development | 49,448 | 58,647 | (9,199 | ) | (15.7 | )% | ||||||||
General and administrative | 27,148 | 25,007 | 2,141 | 8.6 | % | |||||||||
Total operating expenses | 76,596 | 83,654 | (7,058 | ) | (8.4 | )% | ||||||||
Loss from operations | (72,102 | ) | (77,952 | ) | 5,850 | (7.5 | )% | |||||||
Other (expense) income: | ||||||||||||||
Other-than-temporary impairment of investment | (1,160 | ) | — | (1,160 | ) | * | ||||||||
Interest income | 2,278 | 1,562 | 716 | 45.8 | % | |||||||||
Net loss | $ | (70,984 | ) | $ | (76,390 | ) | $ | 5,406 | (7.1 | )% |
• | a decrease in oral brincidofovir clinical expenses of $6.2 million, which is comprised primarily of an $8.7 million decrease related to the completion of our Phase 3 SUPPRESS and AdVise trials and the closeout of our SUSTAIN and SURPASS trials, and a $0.6 million decrease in our expanded access programs, primarily offset by an increase of $1.8 million related to start-up activities for our AdAPT study and an increase of $1.2 million related to conduct of the AdVance study; |
• | a decrease of $1.4 million in oral brincidofovir drug manufacturing costs; |
• | a decrease of $1.9 million related to compensation expense; |
• | a decrease of $0.9 million related to reimbursable BARDA contract expenses; and |
• | a decrease of $0.8 million in supporting research and development expenses; offset by |
• | an increase of approximately $2.4 million mainly related to our development of an IV formulation of brincidofovir, development of CMX521, our clinical candidate for norovirus, and other early stage compounds. |
• | an increase of $2.0 million in global commercial readiness costs; |
• | an increase of $1.0 million in costs related to an indemnification claim; offset by |
• | a decrease of $0.6 million related to compensation expense. |
Years Ended December 31, | Dollar Change | % Change | ||||||||||||
2016 | 2015 | Increase/(Decrease) | ||||||||||||
Revenues: | ||||||||||||||
Contract revenue | $ | 5,702 | $ | 9,214 | $ | (3,512 | ) | (38.1 | )% | |||||
Collaboration and licensing revenue | — | 1,548 | (1,548 | ) | (100 | )% | ||||||||
Total revenues | 5,702 | 10,762 | (5,060 | ) | (47.0 | )% | ||||||||
Operating expenses: | ||||||||||||||
Research and development | 58,647 | 97,717 | (39,070 | ) | (40.0 | )% | ||||||||
General and administrative | 25,007 | 31,296 | (6,289 | ) | (20.1 | )% | ||||||||
Total operating expenses | 83,654 | 129,013 | (45,359 | ) | (35.2 | )% | ||||||||
Loss from operations | (77,952 | ) | (118,251 | ) | 40,299 | (34.1 | )% | |||||||
Other (expense) income: | ||||||||||||||
Interest income, net | 1,562 | 879 | 683 | 77.7 | % | |||||||||
Net loss | $ | (76,390 | ) | $ | (117,372 | ) | $ | 40,982 | (34.9 | )% |
• | a decrease of $31.0 million in oral BCV clinical expenses, comprised primarily of a decrease related to the completion of our Phase 3 SUPRESS and AdVise clinical trials and the closeout of our SUSTAIN and SURPASS clinical trials; |
• | a decrease of $3.1 million in costs related to the development of oral BCV drug manufacturing; and |
• | a decrease in other research and development expenses; offset by |
• | increase in costs of approximately $3.6 million related to the development of an IV formulation of brincidofovir and development of CMX521, our asset for norovirus |
• | a decrease of $7.1 million as we delayed our commercialization readiness activities for brincidofovir; |
• | a decrease of $1.2 million in operational support costs as part of our cost-saving efforts; offset by |
• | a net increase in compensation and other employee related costs of $1.9 million, consisting of an increase of $1.7 million of share-based compensation and an increase of $0.2 million of compensation and benefits. |
Years Ended December 31, | |||||||||||
Cash sources and uses: | 2017 | 2016 | 2015 | ||||||||
Net cash used in operating activities | $ | (50,125 | ) | $ | (63,815 | ) | $ | (99,708 | ) | ||
Net cash provided by (used in) investing activities | 16,431 | 94,065 | (169,496 | ) | |||||||
Net cash provided by financing activities | 779 | 608 | 161,347 | ||||||||
Net (decrease) increase in cash and cash equivalents | $ | (32,915 | ) | $ | 30,858 | $ | (107,857 | ) |
• | the willingness of the FDA and/or foreign regulators to accept the results from Study 999, as well as our other completed and planned clinical and preclinical studies and other work, as the basis for review and approval of brincidofovir for the treatment of AdV infection; |
• | the progress, costs, results and timing of future clinical trials of brincidofovir for other potential indications, including prevention of multiple DNA virus infections and treatment of AdV, BKV and smallpox; |
• | the willingness of the FDA and/or foreign regulators to accept clinical and preclinical studies and other work, as the basis for review and approval of brincidofovir for other potential indications; |
• | the outcome, costs and timing of seeking and obtaining FDA and any other regulatory approvals; |
• | the ability to continue to receive government funding; |
• | the achievement of milestones under our agreement with ContraVir; |
• | the number and characteristics of product candidates that we pursue, including our product candidates in preclinical development; |
• | the ability of our product candidates to progress through clinical development successfully; |
• | our need to expand our research and development activities; |
• | the costs associated with securing, establishing and maintaining commercialization and manufacturing capabilities; |
• | the costs of acquiring, licensing or investing in businesses, products, product candidates and technologies; |
• | our ability to maintain, expand and defend the scope of our intellectual property portfolio, including the amount and timing of any payments we may be required to make, or that we may receive, in connection with the licensing, filing, prosecution, defense and enforcement of any patents or other intellectual property rights; |
• | our need and ability to hire additional management and scientific and medical personnel; |
• | the effect of competing technological and market developments; |
• | our need to implement additional internal systems and infrastructure, including financial and reporting systems; and |
• | the economic and other terms, timing and success of our existing licensing arrangements and any collaboration, licensing or other arrangements into which we may enter in the future. |
Total | Less Than 1 Year | 1 – 3 Years | 3 – 5 Years | More Than 5 Years | |||||||||||||||
Operating leases (1) | $ | 2,347 | $ | 735 | $ | 1,430 | $ | 182 | $ | — | |||||||||
Total | $ | 2,347 | $ | 735 | $ | 1,430 | $ | 182 | $ | — |
(1) | Consists of our corporate headquarters lease encompassing 24,862 square feet of office space that expires in February 2021, and our laboratory leases encompassing a total of approximately 10,274 square feet which are located in Durham and Research Triangle Park, North Carolina and expire in July 2021 and August 2018, respectively. |
Page | |
Reports of Independent Registered Public Accounting Firm | |
Consolidated Balance Sheets as of December 31, 2017 and 2016 | |
Consolidated Statements of Operations and Comprehensive Loss for the Years Ended December 31, 2017, 2016 and 2015 | |
Consolidated Statements of Stockholders’ Equity (Deficit) for the Years Ended December 31, 2017, 2016 and 2015 | |
Consolidated Statements of Cash Flows for the Years Ended December 31, 2017, 2016 and 2015 | |
Notes to Consolidated Financial Statements |
/s/ Ernst & Young LLP |
/s/ Ernst & Young LLP |
December 31, | |||||||
2017 | 2016 | ||||||
ASSETS | |||||||
Current assets: | |||||||
Cash and cash equivalents | $ | 18,548 | $ | 51,463 | |||
Short-term investments, available-for-sale | 132,972 | 180,558 | |||||
Accounts receivable | 1,682 | 1,599 | |||||
Prepaid expenses and other current assets | 3,331 | 2,845 | |||||
Total current assets | 156,533 | 236,465 | |||||
Long-term investments | 76,731 | 47,407 | |||||
Property and equipment, net of accumulated depreciation | 1,894 | 2,843 | |||||
Other long-term assets | 72 | 55 | |||||
Total assets | $ | 235,230 | $ | 286,770 | |||
LIABILITIES AND STOCKHOLDERS' EQUITY | |||||||
Current liabilities: | |||||||
Accounts payable | $ | 3,812 | $ | 3,890 | |||
Accrued liabilities | 9,384 | 6,215 | |||||
Total current liabilities | 13,196 | 10,105 | |||||
Lease-related obligations | 224 | 441 | |||||
Total liabilities | 13,420 | 10,546 | |||||
Stockholders’ equity: | |||||||
Preferred stock, $0.001 par value, 10,000,000 shares authorized at December 31, 2017 and 2016; no shares issued and outstanding as of December 31, 2017 and 2016 | — | — | |||||
Common stock, $0.001 par value; 200,000,000 shares authorized at December 31, 2017 and 2016; 47,505,532 and 46,522,475 shares issued and outstanding at December 31, 2017 and 2016, respectively | 47 | 46 | |||||
Additional paid-in capital | 709,514 | 692,422 | |||||
Accumulated other comprehensive loss, net | (963 | ) | (440 | ) | |||
Accumulated deficit | (486,788 | ) | (415,804 | ) | |||
Total stockholders’ equity | 221,810 | 276,224 | |||||
Total liabilities and stockholders’ equity | $ | 235,230 | $ | 286,770 |
Years Ended December 31, | |||||||||||
2017 | 2016 | 2015 | |||||||||
Revenues: | |||||||||||
Contract revenue | $ | 4,494 | $ | 5,702 | $ | 9,214 | |||||
Collaboration and licensing revenue | — | — | 1,548 | ||||||||
Total revenues | 4,494 | 5,702 | 10,762 | ||||||||
Operating expenses: | |||||||||||
Research and development | 49,448 | 58,647 | 97,717 | ||||||||
General and administrative | 27,148 | 25,007 | 31,296 | ||||||||
Total operating expenses | 76,596 | 83,654 | 129,013 | ||||||||
Loss from operations | (72,102 | ) | (77,952 | ) | (118,251 | ) | |||||
Other (expense) income: | |||||||||||
Other-than-temporary impairment of investment | (1,160 | ) | — | — | |||||||
Interest income, net | 2,278 | 1,562 | 879 | ||||||||
Net loss | (70,984 | ) | (76,390 | ) | (117,372 | ) | |||||
Other comprehensive loss: | |||||||||||
Unrealized (loss) gain on investments, net | (523 | ) | 324 | (799 | ) | ||||||
Comprehensive loss | $ | (71,507 | ) | $ | (76,066 | ) | $ | (118,171 | ) | ||
Per share information: | |||||||||||
Net loss, basic and diluted | $ | (1.51 | ) | $ | (1.65 | ) | $ | (2.67 | ) | ||
Weighted-average shares outstanding, basic and diluted | 46,963,430 | 46,267,064 | 43,878,326 |
Common Stock | Additional Paid-in Capital | Accumulated Other Comprehensive Gain (Loss) | Accumulated Deficit | Total Stockholders’ Equity (Deficit) | |||||||||||||||
Balance, December 31, 2014 | 41 | 496,602 | 35 | (222,042 | ) | 274,636 | |||||||||||||
Share-based compensation | — | 12,959 | — | — | 12,959 | ||||||||||||||
Exercise of stock options | — | 2,107 | — | — | 2,107 | ||||||||||||||
Exercise of warrants | 1 | 1,000 | — | — | 1,001 | ||||||||||||||
Employee stock purchase plan purchases | — | 1,048 | — | — | 1,048 | ||||||||||||||
Issuance of 4,341,250 shares of common stock at $39.75 per share, net of issuance cost of $10,685 | 4 | 161,875 | — | — | 161,879 | ||||||||||||||
Comprehensive loss: | |||||||||||||||||||
Unrealized loss on investments, net | — | — | (799 | ) | — | (799 | ) | ||||||||||||
Net loss | — | — | — | (117,372 | ) | (117,372 | ) | ||||||||||||
Total comprehensive loss | (118,171 | ) | |||||||||||||||||
Balance, December 31, 2015 | 46 | 675,591 | (764 | ) | (339,414 | ) | 335,459 | ||||||||||||
Share-based compensation | — | 16,223 | — | — | 16,223 | ||||||||||||||
Exercise of stock options | — | 168 | — | — | 168 | ||||||||||||||
Employee stock purchase plan purchases | — | 440 | — | — | 440 | ||||||||||||||
Comprehensive loss: | |||||||||||||||||||
Unrealized gain on investments, net | — | — | 324 | — | 324 | ||||||||||||||
Net loss | — | — | — | (76,390 | ) | (76,390 | ) | ||||||||||||
Total comprehensive loss | (76,066 | ) | |||||||||||||||||
Balance, December 31, 2016 | 46 | 692,422 | (440 | ) | (415,804 | ) | 276,224 | ||||||||||||
Share-based compensation | 1 | 16,109 | — | — | 16,110 | ||||||||||||||
Exercise of stock options | — | 121 | — | — | 121 | ||||||||||||||
Employee stock purchase plan purchases | — | 712 | — | — | 712 | ||||||||||||||
University of Michigan stock issuance | — | 150 | — | — | 150 | ||||||||||||||
Comprehensive loss: | |||||||||||||||||||
Unrealized loss on investments, net | — | — | (523 | ) | — | (523 | ) | ||||||||||||
Net loss | — | — | — | (70,984 | ) | (70,984 | ) | ||||||||||||
Total comprehensive loss | (71,507 | ) | |||||||||||||||||
Balance, December 31, 2017 | $ | 47 | $ | 709,514 | $ | (963 | ) | $ | (486,788 | ) | $ | 221,810 |
Years Ended December 31, | |||||||||||
2017 | 2016 | 2015 | |||||||||
Cash flows from operating activities: | |||||||||||
Net loss | $ | (70,984 | ) | $ | (76,390 | ) | $ | (117,372 | ) | ||
Adjustments to reconcile net loss to net cash used in operating activities: | |||||||||||
Depreciation of property and equipment | 1,091 | 1,063 | 657 | ||||||||
Amortization of debt costs | — | — | 64 | ||||||||
Amortization of premium/discount on investments | (5 | ) | 1,223 | 1,622 | |||||||
Share-based compensation | 16,110 | 16,223 | 12,959 | ||||||||
Other-than-temporary impairment of investment | 1,160 | — | — | ||||||||
Amortization of lease-related obligations | (319 | ) | 132 | 19 | |||||||
Changes in operating assets and liabilities: | |||||||||||
Accounts receivable | (83 | ) | 861 | (2,354 | ) | ||||||
Prepaid expenses and other assets | (168 | ) | 3,215 | (3,028 | ) | ||||||
Accounts payable and accrued liabilities | 3,073 | (10,142 | ) | 7,725 | |||||||
Net cash used in operating activities | (50,125 | ) | (63,815 | ) | (99,708 | ) | |||||
Cash flows from investing activities: | |||||||||||
Purchases of property and equipment | (151 | ) | (841 | ) | (2,393 | ) | |||||
Purchases of short-term investments | — | (23,992 | ) | (60,297 | ) | ||||||
Purchases of long-term investments | (162,613 | ) | (79,381 | ) | (234,791 | ) | |||||
Proceeds from sales of short-term investments | 13,500 | — | 1,003 | ||||||||
Proceeds from maturities of short-term investments | 165,695 | 198,279 | 126,742 | ||||||||
Proceeds from maturities of long-term investments | — | — | 240 | ||||||||
Net cash provided by (used in) investing activities | 16,431 | 94,065 | (169,496 | ) | |||||||
Cash flows from financing activities: | |||||||||||
Proceeds from exercise of stock options | 121 | 168 | 2,107 | ||||||||
Proceeds from employee stock purchase plan | 712 | 440 | 1,048 | ||||||||
Proceeds from exercise of warrants | — | — | 1,001 | ||||||||
Proceeds from public offerings, net of offering costs | — | — | 161,879 | ||||||||
Payments of deferred offering costs | (54 | ) | — | — | |||||||
Payments for deferred financing costs | — | — | (338 | ) | |||||||
Repayments of debt | — | — | (4,350 | ) | |||||||
Net cash provided by financing activities | 779 | 608 | 161,347 | ||||||||
Net (decrease) increase in cash and cash equivalents | (32,915 | ) | 30,858 | (107,857 | ) | ||||||
Cash and cash equivalents: | |||||||||||
Beginning of period | 51,463 | 20,605 | 128,462 | ||||||||
End of period | $ | 18,548 | $ | 51,463 | $ | 20,605 | |||||
Supplemental disclosure of cash flow information | |||||||||||
Cash paid for interest | $ | — | $ | — | $ | 158 | |||||
Non-cash addition to deferred offering costs | $ | 276 | $ | — | $ | — |
• | Level 1 — Valuations based on unadjusted quoted prices in active markets for identical assets or liabilities that the Company has the ability to access. |
• | Level 2 — Valuations based on quoted prices for similar assets or liabilities in active markets, quoted prices for identical or similar assets or liabilities in markets that are not active, and models for which all significant inputs are observable, either directly or indirectly. |
• | Level 3 — Valuations based on inputs that are unobservable and significant to the overall fair value measurement. |
Fair Value Measurements | |||||||||||||||
December 31, 2017 | |||||||||||||||
Total | Quoted Prices in Active Markets for Identical Assets (Level 1) | Significant Other Observable Inputs (Level 2) | Significant Unobservable Inputs (Level 3) | ||||||||||||
Cash equivalents | |||||||||||||||
Money market funds | $ | 10,816 | $ | 10,816 | $ | — | $ | — | |||||||
Commercial paper | 3,995 | — | 3,995 | — | |||||||||||
Total cash equivalents | 14,811 | 10,816 | 3,995 | — | |||||||||||
Short-term investments | |||||||||||||||
U.S. Treasury securities | 132,586 | 132,586 | — | — | |||||||||||
Common stock of U.S. corporation | 386 | 386 | — | — | |||||||||||
Total short-term investments | 132,972 | 132,972 | — | — | |||||||||||
Long-term investments | |||||||||||||||
U.S. Treasury securities | 76,731 | 76,731 | — | — | |||||||||||
Total long-term investments | 76,731 | 76,731 | — | — | |||||||||||
Total assets | $ | 224,514 | $ | 220,519 | $ | 3,995 | $ | — |
Fair Value Measurements | |||||||||||||||
December 31, 2016 | |||||||||||||||
Total | Quoted Prices in Active Markets for Identical Assets (Level 1) | Significant Other Observable Inputs (Level 2) | Significant Unobservable Inputs (Level 3) | ||||||||||||
Cash equivalents | |||||||||||||||
Money market funds | $ | 15,733 | $ | 15,733 | $ | — | $ | — | |||||||
Commercial paper | 35,097 | — | 35,097 | — | |||||||||||
Total cash equivalents | 50,830 | 15,733 | 35,097 | — | |||||||||||
Short-term investments | |||||||||||||||
Certificates of deposit | 7,450 | — | 7,450 | — | |||||||||||
U.S. Treasury securities | 171,822 | 171,822 | — | — | |||||||||||
Common stock of U.S. corporation | 1,286 | 1,286 | — | — | |||||||||||
Total short-term investments | 180,558 | 173,108 | 7,450 | — | |||||||||||
Long-term investments | |||||||||||||||
U.S. Treasury securities | 47,407 | 47,407 | — | — | |||||||||||
Total long-term investments | 47,407 | 47,407 | — | — | |||||||||||
Total assets | $ | 278,795 | $ | 236,248 | $ | 42,547 | $ | — |
Fair Value Measurements (Level 3) | |||
Preferred stock of U.S. corporation: | |||
Fair value at December 31, 2015 | 1,485 | ||
Fair value decrease recorded in other comprehensive loss | (371 | ) | |
Fair value transferred to Level 2 | (1,114 | ) | |
Fair value at December 31, 2016 | $ | — |
December 31, | |||||||
2017 | 2016 | ||||||
Prepaid research and development expenses | $ | 1,138 | $ | 843 | |||
Interest receivable | 601 | 772 | |||||
Prepaid insurance | 481 | 389 | |||||
Other prepaid expenses and current assets | 1,111 | 841 | |||||
Total prepaid expenses and other current assets | $ | 3,331 | $ | 2,845 |
December 31, | |||||||
2017 | 2016 | ||||||
Accrued compensation | $ | 3,678 | $ | 2,906 | |||
Accrued research and development expenses | 3,384 | 2,257 | |||||
Accrued indemnification claim | 1,000 | — | |||||
Other accrued liabilities | 1,322 | 1,052 | |||||
Total accrued liabilities | $ | 9,384 | $ | 6,215 |
December 31, 2017 | |||||||||||||||
Amortized Cost | Gross Unrealized Gains | Gross Unrealized Losses | Estimated Fair Value | ||||||||||||
U.S. Treasury securities | $ | 210,280 | $ | — | $ | (963 | ) | $ | 209,317 | ||||||
Common stock of U.S. corporation | 386 | — | — | 386 | |||||||||||
Total investments | $ | 210,666 | $ | — | $ | (963 | ) | $ | 209,703 |
December 31, 2016 | |||||||||||||||
Amortized Cost | Gross Unrealized Gains | Gross Unrealized Losses | Estimated Fair Value | ||||||||||||
Certificates of deposit | $ | 7,445 | $ | 5 | $ | — | $ | 7,450 | |||||||
U.S. Treasury securities | 219,415 | 15 | (201 | ) | 219,229 | ||||||||||
Common stock of U.S. corporation | 1,545 | — | (259 | ) | 1,286 | ||||||||||
Total investments | $ | 228,405 | $ | 20 | $ | (460 | ) | $ | 227,965 |
December 31, 2017 | ||||||||||||||||||||||||
Less than 12 Months | Greater than 12 Months | Total | ||||||||||||||||||||||
Fair Value | Unrealized Loss | Fair Value | Unrealized Loss | Fair Value | Unrealized Loss | |||||||||||||||||||
U.S. Treasury securities | $ | 170,390 | $ | (871 | ) | $ | 38,927 | $ | (92 | ) | $ | 209,317 | $ | (963 | ) | |||||||||
Total | $ | 170,390 | $ | (871 | ) | $ | 38,927 | $ | (92 | ) | $ | 209,317 | $ | (963 | ) | |||||||||
Number of securities with unrealized losses | 39 | 7 | 46 |
December 31, 2016 | ||||||||||||||||||||||||
Less than 12 Months | Greater than 12 Months | Total | ||||||||||||||||||||||
Fair Value | Unrealized Loss | Fair Value | Unrealized Loss | Fair Value | Unrealized Loss | |||||||||||||||||||
U.S. Treasury securities | $ | 128,204 | $ | (201 | ) | $ | — | $ | — | $ | 128,204 | $ | (201 | ) | ||||||||||
Preferred stock of U.S. corporation | 1,286 | (259 | ) | — | — | 1,286 | $ | (259 | ) | |||||||||||||||
Total | $ | 129,490 | $ | (460 | ) | $ | — | $ | — | $ | 129,490 | $ | (460 | ) | ||||||||||
Number of securities with unrealized losses | 24 | — | 24 |
December 31, 2017 | |||
Maturing in one year or less | $ | 132,586 | |
Maturing after one year through two years | 76,731 | ||
Total debt investments | $ | 209,317 | |
Common stock of U.S. corporation | 386 | ||
Total investments | $ | 209,703 |
December 31, | |||||||
2017 | 2016 | ||||||
Lab equipment | $ | 2,496 | $ | 2,419 | |||
Leasehold improvements | 1,552 | 1,570 | |||||
Computer equipment | 1,170 | 1,262 | |||||
Office furniture and equipment | 520 | 586 | |||||
Property and equipment | 5,738 | 5,837 | |||||
Less accumulated depreciation | (3,844 | ) | (2,994 | ) | |||
Property and equipment, net of accumulated depreciation | $ | 1,894 | $ | 2,843 |
Years Ending December 31, | Minimum Rental Payment | ||
2018 | $ | 735 | |
2019 | 711 | ||
2020 | 720 | ||
2021 | 182 | ||
Total future minimum rental payments | $ | 2,348 |
Years Ending December 31, | Minimum Sublease Rentals | ||
2018 | $ | 75 | |
2019 | 78 | ||
2020 | 81 | ||
2021 | 14 | ||
Total future minimum sublease rentals | $ | 248 |
December 31, | |||||
2017 | 2016 | ||||
For exercise of common stock warrants | 227,794 | 227,794 | |||
For exercise of outstanding common stock options | 4,996,661 | 4,342,466 | |||
For delivery upon vesting of outstanding restricted stock units | 956,299 | 946,200 | |||
For future equity awards under the 2013 Equity Incentive Plan | 1,082,608 | 662,180 | |||
For future purchases under the 2013 Employee Stock Purchase Plan | 1,861,472 | 1,612,759 | |||
Total shares of common stock reserved for future issuances | 9,124,834 | 7,791,399 |
Years Ended December 31, | |||||||||||
2017 | 2016 | 2015 | |||||||||
Expected volatility | 85.51 | % | 85.16 | % | 66.89 | % | |||||
Expected term (in years) | 5.9 | 6.0 | 6.0 | ||||||||
Weighted-average risk-free interest rate | 2.02 | % | 1.70 | % | 1.53 | % | |||||
Expected dividend yield | — | % | — | % | — | % | |||||
Weighted-average fair value per option | $ | 3.71 | $ | 5.62 | $ | 25.18 |
Number of Options Outstanding | Weighted-Average Exercise Price | Weighted-Average Remaining Contractual Life (in Years) | Total Intrinsic Value | ||||||||||
Balance, December 31, 2015 | 2,746,395 | $ | 28.19 | 8.41 | |||||||||
Granted | 2,418,551 | 7.76 | — | ||||||||||
Exercised | (48,441 | ) | 3.48 | — | |||||||||
Forfeited | (774,039 | ) | 24.13 | — | |||||||||
Balance, December 31, 2016 | 4,342,466 | $ | 17.81 | 8.09 | |||||||||
Granted | 928,816 | 5.17 | — | ||||||||||
Exercised | (38,885 | ) | 3.98 | — | |||||||||
Forfeited | (235,736 | ) | 19.10 | — | |||||||||
Balance, December 31, 2017 | 4,996,661 | $ | 15.51 | 7.59 | $ | 529,145 | |||||||
Exercisable at December 31, 2017 | 3,021,179 | $ | 18.05 | 7.14 | $ | 516,430 | |||||||
Vested or expected to vest at December 31, 2017 | 4,934,708 | $ | 15.56 | 7.58 | $ | 527,433 |
Years Ended December 31, | ||||||||||||
2017 | 2016 | 2015 | ||||||||||
Weighted-average grant-date fair value per share of options granted | $ | 3.71 | $ | 5.62 | $ | 25.18 | ||||||
Total intrinsic value of options exercised | $ | 48 | $ | 119 | $ | 10,139 | ||||||
Total fair value of shares vested | $ | 11,786 | $ | 13,330 | $ | 11,498 |
Outstanding | Exercisable | |||||||||||||||
Range | Number | Weighted-Average Remaining Contractual Life (in years) | Weighted-Average Exercise Price | Number | Weighted-Average Exercise Price | |||||||||||
$1.53 to 7.57 | 1,324,631 | 8.10 | $ | 4.65 | 631,032 | $ | 4.11 | |||||||||
7.58 to 8.06 | 1,885,674 | 8.02 | 8.06 | 907,919 | 8.06 | |||||||||||
8.07 to 18.75 | 381,805 | 6.05 | 17.73 | 373,743 | 17.72 | |||||||||||
18.76 to 39.17 | 564,854 | 6.56 | 25.39 | 492,529 | 25.09 | |||||||||||
39.18 to 53.74 | 839,697 | 7.21 | 41.70 | 615,956 | 41.61 | |||||||||||
$1.53 to 53.74 | 4,996,661 | 7.59 | $ | 15.51 | 3,021,179 | $ | 18.05 |
Years Ended December 31, | |||||||||||
2017 | 2016 | 2015 | |||||||||
Expected volatility | 77.18 | % | 111.57 | % | 57.77 | % | |||||
Expected term (in years) | 0.97 | 1.37 | 1.1 | ||||||||
Weighted-average risk-free interest rate | 0.99 | % | 0.75 | % | 0.43 | % | |||||
Expected dividend yield | — | % | — | % | — | % | |||||
Weighted-average option value per share | $ | 2.65 | $ | 3.20 | $ | 22.10 |
Number of Restricted Stock Units Outstanding | Weighted-Average Grant-Date Fair Value | ||||
Balance, December 31, 2016 | 946,200 | $ | 4.91 | ||
Granted | 879,300 | 5.12 | |||
Share issuance | (744,450 | ) | 4.91 | ||
Forfeited | (124,751 | ) | 5.09 | ||
Balance, December 31, 2017 | 956,299 | $ | 5.08 |
Years Ended December 31, | |||||||||||
2017 | 2016 | 2015 | |||||||||
Income Statement Classification: | |||||||||||
Research and development expense | $ | 7,047 | $ | 7,137 | $ | 5,578 | |||||
General and administrative expense | 9,063 | 9,086 | 7,381 | ||||||||
Total stock-based compensation expense | $ | 16,110 | $ | 16,223 | $ | 12,959 |
2017 | 2016 | 2015 | ||||||||||||||||||
Amount | % of Pretax Earnings | Amount | % of Pretax Earnings | Amount | % of Pretax Earnings | |||||||||||||||
Income tax benefit at statutory rate | $ | (24,134 | ) | 34.0 | % | $ | (25,973 | ) | 34.0 | % | $ | (39,907 | ) | 34.0 | % | |||||
State income taxes | (1,090 | ) | 1.5 | % | (1,544 | ) | 2.0 | % | (2,176 | ) | 1.9 | % | ||||||||
Research and development credits | (2,039 | ) | 2.9 | % | (2,691 | ) | 3.5 | % | (5,698 | ) | 4.9 | % | ||||||||
Foreign rate differential | 60 | (0.1 | )% | (2 | ) | — | % | 2 | — | % | ||||||||||
Permanent items | 1,646 | (2.3 | )% | 2,537 | (3.3 | )% | 3,687 | (3.1 | )% | |||||||||||
Provision to return adjustments | 1,212 | (1.7 | )% | 259 | (0.3 | )% | (426 | ) | 0.2 | % | ||||||||||
Effect of change in federal tax rate | 57,950 | (81.6 | )% | — | — | % | — | — | % | |||||||||||
Effect of change in state tax rate | 193 | (0.3 | )% | 1,585 | (2.1 | )% | 932 | (0.8 | )% | |||||||||||
Removal of excess tax benefit | (12,930 | ) | 18.2 | % | — | — | % | — | — | % | ||||||||||
Increase in unrecognized tax benefits | 403 | (0.6 | )% | 444 | (0.6 | )% | 950 | (0.8 | )% | |||||||||||
Change in valuation allowance | (21,271 | ) | 30.0 | % | 25,385 | (33.2 | )% | 42,636 | (36.3 | )% | ||||||||||
Net benefit | $ | — | — | % | $ | — | — | % | $ | — | — | % |
December 31, | |||||||
2017 | 2016 | ||||||
Deferred tax assets: | |||||||
Domestic net operating loss carryforwards | $ | 92,020 | $ | 114,111 | |||
Foreign net operating loss carryforwards | 61 | — | |||||
Research and development expenses | 763 | 813 | |||||
Capitalized Section 174 expenses | 28 | 48 | |||||
Research and development credits | 12,437 | 10,907 | |||||
Accrued bonuses | 777 | 1,006 | |||||
Share-based compensation | 6,156 | 7,214 | |||||
Other | 983 | 460 | |||||
Total gross deferred tax assets | 113,225 | 134,559 | |||||
Valuation allowance | (113,225 | ) | (134,496 | ) | |||
Total deferred tax assets | — | 63 | |||||
Deferred tax liabilities: | |||||||
Other | — | (63 | ) | ||||
Total deferred tax liabilities | — | (63 | ) | ||||
Total deferred tax assets and liabilities, net | $ | — | $ | — |
Balance at December 31, 2015 | $ | 1,956 | |
Increases related to 2016 | 444 | ||
Increases related to prior periods | — | ||
Balance at December 31, 2016 | 2,400 | ||
Increases related to 2017 | 403 | ||
Increases related to prior periods | 473 | ||
Balance at December 31, 2017 | $ | 3,276 |
2017 Quarters | |||||||||||||||
Fourth | Third | Second | First | ||||||||||||
Total revenues | $ | 1,844 | $ | 897 | $ | 675 | $ | 1,078 | |||||||
Operating loss | (18,687 | ) | (17,910 | ) | (17,245 | ) | (18,260 | ) | |||||||
Net loss | (19,238 | ) | (17,312 | ) | (16,680 | ) | (17,754 | ) | |||||||
Net loss per share, basic and diluted | $ | (0.41 | ) | $ | (0.37 | ) | $ | (0.36 | ) | $ | (0.38 | ) | |||
Weighted-average shares outstanding, basic and diluted | 47,341,271 | 47,065,756 | 46,863,753 | 46,573,394 |
2016 Quarters | |||||||||||||||
Fourth | Third | Second | First | ||||||||||||
Total revenues | $ | 1,980 | $ | 653 | $ | 1,841 | $ | 1,228 | |||||||
Operating loss | (15,373 | ) | (17,422 | ) | (18,525 | ) | (26,632 | ) | |||||||
Net loss | (14,957 | ) | (17,025 | ) | (18,148 | ) | (26,260 | ) | |||||||
Net loss per share, basic and diluted | $ | (0.32 | ) | $ | (0.37 | ) | $ | (0.39 | ) | $ | (0.57 | ) | |||
Weighted-average shares outstanding, basic and diluted | 46,431,809 | 46,236,749 | 46,214,086 | 46,184,134 |
i. | pertain to the maintenance of records, that, in reasonable detail, accurately and fairly reflect the transactions and dispositions of our assets; |
ii. | provide reasonable assurance that transactions are recorded as necessary to permit preparations of financial statements in accordance with generally accepted accounting principles, and that our receipts and expenditures are being made only in accordance with authorizations of our management and directors; and |
iii. | provide reasonable assurance regarding prevention or timely detection of unauthorized acquisition, use or disposition of our assets that could have a material effect on the financial statements. |
Exhibit Number | Description of Document | |
3.1 (1) | ||
3.2 (1) | ||
4.1 (1) | ||
10.1+ (1) | ||
10.2+ (1) | ||
10.3+ (1) | ||
10.4+(17) | ||
10.5+ (2) | ||
10.6+ (1) | ||
10.7+(20) | ||
10.8+ (9) | ||
10.9+ (1) | ||
10.10+ (1) | ||
10.11+ (7) | ||
10.12 (3) | ||
10.13+ (1) | ||
10.14+ (13) | ||
10.15+ (13) | ||
10.16+ (13) | ||
10.17+ (13) | ||
10.18 (1) | ||
10.19 (6) | ||
10.20 (5) | ||
10.21 (10) | ||
10.22 (18) | ||
10.23 (19) |
10.24* (1) | ||
10.25* (8) | ||
10.26* (9) | ||
10.27* (9) | ||
10.28 (4) | ||
10.29 (13) | ||
10.30* (5) | ||
10.31 (5) | ||
10.32* (13) | ||
10.33 (13) | ||
10.34 (13) | ||
10.35 (13) | ||
10.36 (10) | ||
10.37 (11) | ||
10.38 (11) | ||
10.39* (12) | ||
10.40* (12) | ||
10.41* (14) | ||
10.42* (15) | ||
10.43* (15) |
10.44* (16) | ||
10.45* (17) | ||
10.46 (18) | ||
10.47 (18) | ||
10.48 (19) | ||
10.49 (20) | ||
10.50 (20) | ||
10.51 (20) | ||
10.52 (21) | ||
10.53 (21) | ||
10.54 (21) | ||
10.55 (21) | ||
10.56 | ||
10.57 | ||
10.58** | ||
10.59 | ||
10.60** |
10.61*(18) | ||
10.62*(1) | ||
10.63(22) | ||
10.64 | ||
23.1 | ||
24.1 | ||
31.1 | ||
31.2 | ||
32.1 | ||
32.2 | ||
101.INS | XBRL Instance Document. | |
101.SCH | XBRL Taxonomy Extension Schema Document. | |
101.CAL | XBRL Taxonomy Extension Calculation Linkbase Document. | |
101.DEF | XBRL Taxonomy Extension Definition Linkbase Document. | |
101.LAB | XBRL Taxonomy Extension Label Linkbase Document. | |
101.PRE | XBRL Taxonomy Extension Presentation Linkbase Document. |
+ | Indicates management contract or compensatory plan. | |
* | Confidential treatment has been granted with respect to certain portions of this exhibit. Omitted portions have been filed separately with the SEC. | |
** | Confidential treatment has been requested with respect to certain portions of this exhibit. Omitted portions have been filed separately with the SEC. | |
(1) | Incorporated by reference to Chimerix, Inc.’s Registration Statement on Form S-1 (No. 333-187145), as amended. | |
(2) | Incorporated by reference to Chimerix, Inc.’s Current Report on Form 8-K (No. 001-35867) filed with the SEC on June 23, 2014. | |
(3) | Incorporated by reference to Chimerix, Inc.’s Current Report on Form 8-K (No. 001-35867) filed with the SEC on September 4, 2014. | |
(4) | Incorporated by reference to Chimerix, Inc.’s Quarterly Report on Form 10-Q (No. 001-35867) filed with the SEC on May 9, 2014. | |
(5) | Incorporated by reference to Chimerix, Inc.’s Quarterly Report on Form 10-Q (No. 001-35867) filed with the SEC on November 7, 2014. | |
(6) | Incorporated by reference to Chimerix, Inc.’s Current Report on Form 8-K (No. 001-35867) filed with the SEC on March 14, 2014. | |
(7) | Incorporated by reference to Chimerix, Inc.’s Current Report on Form 8-K (No. 001-35867) filed with the SEC on December 18, 2013. | |
(8) | Incorporated by reference to Chimerix, Inc.’s Quarterly Report on Form 10-Q (No. 001-35867) filed with the SEC on August 14, 2013. | |
(9) | Incorporated by reference to Chimerix, Inc.’s Annual Report on Form 10-K (No. 001-35867) filed with the SEC on March 7, 2014. | |
(10) | Incorporated by reference to Chimerix, Inc.'s Quarterly Report on Form 10-Q (No. 001-35867) filed with the SEC on May 11, 2015. | |
(11) | Incorporated by reference to Chimerix, Inc.'s Quarterly Report on Form 10-Q (No. 001-35867) filed with the SEC on August 6, 2015. | |
(12) | Incorporated by reference to Chimerix, Inc.'s Quarterly Report on Form 10-Q (No. 001-35867) filed with the SEC on November 5, 2015. | |
(13) | Incorporated by reference to Chimerix, Inc.’s Annual Report on Form 10-K (No. 001-35867) filed with the SEC on March 6, 2015. | |
(14) | Incorporated by reference to Chimerix, Inc.’s Annual Report on Form 10-K (No. 001-35867) filed with the SEC on February 29, 2016 | |
(15) | Incorporated by reference to Chimerix, Inc.’s Quarterly Report on Form 10-Q (No. 001-35867) filed with the SEC on May 9, 2016. | |
(16) | Incorporated by reference to Chimerix, Inc.’s Quarterly Report on Form 10-Q (No. 001-35867) filed with the SEC on August 8, 2016. | |
(17) | Incorporated by reference to Chimerix, Inc.’s Quarterly Report on Form 10-Q (No. 001-35867) filed with the SEC on November 7, 2016. | |
(18) | Incorporated by reference to Chimerix, Inc.’s Annual Report on Form 10-K (No. 001-35867) filed with the SEC on March 2, 2017. | |
(19) | Incorporated by reference to Chimerix, Inc.’s Quarterly Report on Form 10-Q (No. 001-35867) filed with the SEC on May 9, 2017. | |
(20) | Incorporated by reference to Chimerix, Inc.’s Quarterly Report on Form 10-Q (No. 001-35867) filed with the SEC on August 7, 2017. | |
(21) | Incorporated by reference to Chimerix, Inc.’s Current Report on Form 8-K (No. 001-35867) filed with the SEC on October 11, 2017. |
Chimerix, Inc. | |||||
Date: | March 1, 2018 | By: | /s/ M. Michelle Berrey | ||
M. Michelle Berrey, MD, MPH | |||||
President & Chief Executive Officer |
Signature | Title | Date | ||
/s/ M. Michelle Berrey | President, Chief Executive Officer and Director | March 1, 2018 | ||
M. Michelle Berrey, MD, MPH | (Principal Executive Officer) | |||
/s/ Timothy W. Trost | Senior Vice President, Chief Financial Officer | March 1, 2018 | ||
Timothy W. Trost | and Corporate Secretary | |||
(Principal Financial and Accounting Officer) | ||||
/s/ Ernest Mario | ||||
Ernest Mario, PhD | Chairman of the Board of Directors | March 1, 2018 | ||
/s/ James M. Daly | ||||
James M. Daly | Member of the Board of Directors | March 1, 2018 | ||
/s/ Catherine L. Gilliss | ||||
Catherine L. Gilliss, PhD, RN, FAAN | Member of the Board of Directors | March 1, 2018 | ||
/s/ Patrick Machado | ||||
Patrick Machado | Member of the Board of Directors | March 1, 2018 | ||
/s/ James Niedel | ||||
James Niedel, MD, PhD | Member of the Board of Directors | March 1, 2018 |
AMENDMENT OF SOLICITATION/MODIFICATION OF CONTRACT | 1. CONTRACT ID CODE | PAGE OF PAGES | ||||||||||
1 | 2 | |||||||||||
2. AMENDMENT/MODIFICATION NO 0045 | 3. EFFECTIVE DATE See Block 16C | 4. REQUISITION/PURCHASE REQ NO N/A. | 5. PROJECT NO (if applicable) | |||||||||
6. ISSUED BY CODE | ASPR-BARDA | 7. ADMINISTERED BY (if other than line item 6) CODE | ASPR-BARDA02 | |||||||||
ASPR-BARDA 200 Independence Ave., S.W. Room 640-G Washington DC 20201 | ASPR-BARDA 330 Independence Ave., SW, Rm G640 Washington DC 20201 | |||||||||||
8. NAME AND ADDRESS OF CONTRACTOR (No, street, county, State and ZIP Code) | (x) | 9A AMENDMENT OF SOLICITATION NO. | ||||||||||
CHIMERIX, INC. 1377270 CHIMERIX, INC. 2505 MERIDIAN P 2505 MERIDIAN PKWY STE 340 DURHAM NC 277135246 | ||||||||||||
9B DATED (SEE ITEM 11) | ||||||||||||
x | 10A MODIFICATION OF CONTRACT/ORDER NO HHSO100201100013C | |||||||||||
10B DATED (SEE ITEM 13) 02/16/2011 | ||||||||||||
CODE 1377270 | FACILITY CODE | |||||||||||
11. THIS ITEM ONLY APPLIES TO AMENDMENTS OF SOLICITATIONS | ||||||||||||
¨ The above numbered solicitation is amended as set forth in Item 14. The hour and date specified of receipt of Offers ¨ is extended. ¨ is not extended Offers must acknowledge receipt of this amendment prior to the hour end dale specified in the solicitation or as amended, by one or the following methods: (a) By completing Items 8 and 15, and returning __________ copies of the amendment; (b) By acknowledging receipt of this amendment on each copy of the offer submitted; or (c) By separate letter or telegram which includes a reference to the solicitation and amendment numbers. FAILURE OF YOUR ACKNOWLEDGEMENT TO BE RECEIVED AT THE PLACE DESIGNATED FOR THE RECEIPT OF OFFERS PRIOR TO THE HOUR AND DATE SPECIFIED MAY RESULT IN REJECTION OF YOUR OFFER. If by virtue of this amendment you desire to change an offer already submitted, such change may be made by telegram or letter, provided each telegram or letter makes reference to the solicitation and this amendment, and is received prior to the opening hour and date specified. | ||||||||||||
12. ACCOUNTING AND APPROPRIATION DATA (if required) N/A. | ||||||||||||
13. THIS ITEM ONLY APPLIES TO MODIFICATION OF CONTRACTS/ORDERS. IT MODIFIES THE CONTRACT/ORDER NO. AS DESCRIBED IN ITEM 14. | ||||||||||||
CHECK ONE | A. THIS CHANGE ORDER IS ISSUED PURSUANT TO (Specify authority) THE CHANGES SET FORTH IN ITEM 14 ARE MADE IN THE CONTRACT ORDER NO IN ITEM 10A | |||||||||||
B. THE ABOVE NUMBERED CONTRACT/ORDER IS MODIFIED TO REFLECT THE ADMINISTRATIVE CHANGES (such as changes in paying office, appropriation date, etc.) SET FORTH IN ITEM 14, PURSUANT TO THE AUTHORITY OF FAR 43.103(b). | ||||||||||||
C. THIS SUPPLEMENTAL AGREEMENT IS ENTERED INTO PURSUANT TO AUTHORITY OF | ||||||||||||
X | D. OTHER (Specify type of modification and authority) Bilateral: Mutual Agreement of the Parties. | |||||||||||
E. IMPORTANT: Contractor ¨ is not. ý is required to sign this document and return 0 copies to the issuing office. | ||||||||||||
14. DESCRIPTION OF AMENDMENT/MODIFICATION (Organized by UCF section headings, including solicitation/contract subject matter where feasible) Tax ID Number: 33-0903395 DUNS Number: 121785997 A. The purpose of this modification is to incorporate the following changes into the contract: 1. The period of performance for Option 2/CLIN 0003 of Contract Number HHS0100201100013C ONLY is hereby changed from 1 September 2014 through 31 October 2017 to 1 September 2014 through 8 December 2017, at no additional cost to the Government. The total amount and scope of Option 2/CLIN 0003 of Contract Number HHSO100201100013C remains unchanged. 2. The period of performance for CLIN 0004 of Contract Number HHSO100201100013C ONLY is Continued ... Except as provided herein, all terms and conditions of the document referenced in Item 9A or 10A, as heretofore changed, remains unchanged and in full force and effect. | ||||||||||||
15A. NAME AND TITLE OF SIGNER (Type or print) Timothy W. Trost, SVP & CFO | 16A. NAME AND TITLE OF CONTRACTING OFFICER (Type or print) ETHAN J. MUELLER | |||||||||||
15B. CONTRACTOR/OFFEROR /s/ Timothy W. Trost (Signature of person authorized to sign) | 15C. DATE SIGNED 18 Oct 2017 | 16B. UNITED STATES OF AMERICA /s/ Ethan J. Mueller (Signature of person authorized to sign) | 16C. DATE SIGNED 10/20/17 |
CONTINUATION SHEET | REFERENCE NO. OF DOCUMENT BEING CONTINUED HHSO100201100013C/0045 | PAGE OF | ||||||
2 | 2 | |||||||
NAME OF OFFEROR OR CONTRACTOR CHIMERIX, INC. 1377270 | ||||||||
ITEM NO. (A) | SUPPLIES/SERVICES (B) | QUANTITY (C) | UNIT (D) | UNIT PRICE (E) | AMOUNT (F) | |||
hereby changed from 11 September 2015 through 31 October 2017 to September 2015 through 8 December 2017, at no additional cost to the Government. The total amount and scope of CLIN 0004 of Contract Number HHSO100201100013C remains unchanged. 3. The total amount, scope and period of performance of all other CLINs that are currently being performed under the contract remain unchanged. This modification does not exercise any unexercised Option CLINs under the contract and does not authorize any performance of efforts under any unexercised Option CLINs under the contract. In addition, the total amount, scope and period of performance of all unexercised option CLINs under the contract remain unchanged. This modification also confirms that all activities under the base period of performance CLIN 0001 were completed as of 31 May 2013 and confirms that all activities under the Option 1/CLIN 0002 period of performance were completed as of 30 April 2015. B. This is a no cost bilateral modification. All other terms and conditions of Contract Number HHSO100201100013C remain unchanged. Period of Performance: 02/16/2011 to 12/08/2017 |
AMENDMENT OF SOLICITATION/MODIFICATION OF CONTRACT | 1. CONTRACT ID CODE | PAGE OF PAGES | ||||||||
1 | 2 | |||||||||
2. AMENDMENT/MODIFICATION NO 0046 | 3. EFFECTIVE DATE See Block 16C | 4. REQUISITION/PURCHASE REQ NO N/A. | 5. PROJECT NO (if applicable) | |||||||
6. ISSUED BY CODE | ASPR-BARDA | 7. ADMINISTERED BY (if other than line item 6) CODE | ASPR-BARDA02 | |||||||
ASPR-BARDA 200 Independence Ave., S.W. Room 640-G Washington DC 20201 | ASPR-BARDA 330 Independence Ave., SW, Rm G640 Washington DC 20201 | |||||||||
8. NAME AND ADDRESS OF CONTRACTOR (No, street, county, State and ZIP Code) | (x) | 9A AMENDMENT OF SOLICITATION NO. | ||||||||
CHIMERIX, INC. 1377270 CHIMERIX, INC. 2505 MERIDIAN P 2505 MERIDIAN PKWY STE 340 DURHAM NC 277135246 | ||||||||||
9B DATED (SEE ITEM 11) | ||||||||||
X | 10A MODIFICATION OF CONTRACT/ORDER NO HHSO100201100013C | |||||||||
10B DATED (SEE ITEM 13) 02/16/2011 | ||||||||||
CODE 1377270 | FACILITY CODE | |||||||||
11. THIS ITEM ONLY APPLIES TO AMENDMENTS OF SOLICITATIONS | ||||||||||
¨ The above numbered solicitation is amended as set forth in Item 14. The hour and date specified of receipt of Offers ¨ is extended. ¨ is not extended Offers must acknowledge receipt of this amendment prior to the hour end dale specified in the solicitation or as amended, by one or the following methods: (a) By completing Items 8 and 15, and returning __________ copies of the amendment; (b) By acknowledging receipt of this amendment on each copy of the offer submitted; or (c) By separate letter or telegram which includes a reference to the solicitation and amendment numbers. FAILURE OF YOUR ACKNOWLEDGEMENT TO BE RECEIVED AT THE PLACE DESIGNATED FOR THE RECEIPT OF OFFERS PRIOR TO THE HOUR AND DATE SPECIFIED MAY RESULT IN REJECTION OF YOUR OFFER. If by virtue of this amendment you desire to change an offer already submitted, such change may be made by telegram or letter, provided each telegram or letter makes reference to the solicitation and this amendment, and is received prior to the opening hour and date specified. | ||||||||||
12. ACCOUNTING AND APPROPRIATION DATA (if required) N/A. | ||||||||||
13. THIS ITEM ONLY APPLIES TO MODIFICATION OF CONTRACTS/ORDERS. IT MODIFIES THE CONTRACT/ORDER NO. AS DESCRIBED IN ITEM 14. | ||||||||||
CHECK ONE | A. THIS CHANGE ORDER IS ISSUED PURSUANT TO (Specify authority) THE CHANGES SET FORTH IN ITEM 14 ARE MADE IN THE CONTRACT ORDER NO IN ITEM 10A | |||||||||
B. THE ABOVE NUMBERED CONTRACT/ORDER IS MODIFIED TO REFLECT THE ADMINISTRATIVE CHANGES (such as changes in paying office, appropriation date, etc.) SET FORTH IN ITEM 14, PURSUANT TO THE AUTHORITY OF FAR 43.103(b). | ||||||||||
C. THIS SUPPLEMENTAL AGREEMENT IS ENTERED INTO PURSUANT TO AUTHORITY OF | ||||||||||
X | D. OTHER (Specify type of modification and authority) Bilateral: Mutual Agreement of the Parties. | |||||||||
E. IMPORTANT: Contractor ¨ is not. ý is required to sign this document and return 0 copies to the issuing office. | ||||||||||
14. DESCRIPTION OF AMENDMENT/MODIFICATION (Organized by UCF section headings, including solicitation/contract subject matter where feasible) Tax ID Number: 33-0903395 DUNS Number: 121785997 A. The purpose of this modification is to incorporate the following changes into the contract: 1. The period of performance for Option 2/CLIN 0003 of Contract Number HHSO100201100013C ONLY I hereby changed from 1 September 2014 through 8 December 2017 to 1 September 2014 through 31 December 2017, at no additional cost to the Government. The total amount and scope of Option 2/CLIN 0003 of Contract Number HHSO100201100013C remains unchanged. 2. The period of performance for CLIN 0004 of Contract Number HHSO100201100013C ONLY is Continued ... Except as provided herein, all terms and conditions of the document referenced in Item 9A or 10A, as heretofore changed, remains unchanged and in full force and effect. | ||||||||||
15A. NAME AND TITLE OF SIGNER (Type or print) Timothy W. Trost, SVP & CFO | 16A. NAME AND TITLE OF CONTRACTING OFFICER (Type or print) ETHAN J. MUELLER | |||||||||
15B. CONTRACTOR/OFFEROR /s/ Timothy W. Trost (Signature of person authorized to sign) | 15C. DATE SIGNED 11/21/17 | 16B. UNITED STATES OF AMERICA /s/ Ethan J. Mueller (Signature of person authorized to sign) | 16C. DATE SIGNED 11/27/17 |
CONTINUATION SHEET | REFERENCE NO. OF DOCUMENT BEING CONTINUED HHSO100201100013C/0046 | PAGE OF | ||||||
2 | 2 | |||||||
NAME OF OFFEROR OR CONTRACTOR CHIMERIX, INC. 1377270 | ||||||||
ITEM NO. (A) | SUPPLIES/SERVICES (B) | QUANTITY (C) | UNIT (D) | UNIT PRICE (E) | AMOUNT (F) | |||
Hereby changed from 11 September 2015 through 8 December 2017 to 11 September 2015 through 31 December 2017, at no additional cost to the Government. The total amount and scope of CLIN 0004 of Contract Number HHSO100201100013C remains unchanged. 3. The total amount, scope and period of performance of all other CLINs that are currently being performed under the contract remain unchanged. This modification does not exercise any unexercised Option CLINs under the contract and does not authorize any performance of efforts under any unexercised Option CLINs under the contract. In addition, the total amount, scope and period of performance of all unexercised Option CLINs under the contract remain unchanged. This modification also confirms that all activities under the base period of performance CLIN 0001 were completed as of 31 May 2013 and confirms that all activities under the Option 1/CLIN 0002 period of performance were completed as of 30 April 2015. B. This is no cost bilaterla modification. All other terms and conditions of Contract Number HHSO100201100013C remain unchanged. Period of Performance: 02/16/2011 to 12/31/2017 |
AMENDMENT OF SOLICITATION/MODIFICATION OF CONTRACT | 1. CONTRACT ID CODE | PAGE OF PAGES | ||||||||||
1 | 18 | |||||||||||
2. AMENDMENT/MODIFICATION NO 0047 | 3. EFFECTIVE DATE See Block 16C | 4. REQUISITION/PURCHASE REQ NO OS212384 | 5. PROJECT NO (if applicable) | |||||||||
6. ISSUED BY CODE | ASPR-BARDA | 7. ADMINISTERED BY (if other than line item 6) CODE | ASPR-BARDA02 | |||||||||
ASPR-BARDA 200 Independence Ave., S.W. Room 640-G Washington DC 20201 | ASPR-BARDA 330 Independence Ave., SW, Rm G640 Washington DC 20201 | |||||||||||
8. NAME AND ADDRESS OF CONTRACTOR (No, street, county, State and ZIP Code) | (x) | 9A AMENDMENT OF SOLICITATION NO. | ||||||||||
CHIMERIX, INC. 1377270 CHIMERIX, INC. 2505 MERIDIAN P 2505 MERIDIAN PKWY STE 340 DURHAM NC 277135246 | ||||||||||||
9B DATED (SEE ITEM 11) | ||||||||||||
x | 10A MODIFICATION OF CONTRACT/ORDER NO HHSO100201100013C | |||||||||||
10B DATED (SEE ITEM 13) 02/16/2011 | ||||||||||||
CODE 1377270 | FACILITY CODE | |||||||||||
11. THIS ITEM ONLY APPLIES TO AMENDMENTS OF SOLICITATIONS | ||||||||||||
¨ The above numbered solicitation is amended as set forth in Item 14. The hour and date specified of receipt of Offers ¨ is extended. ¨ is not extended Offers must acknowledge receipt of this amendment prior to the hour end dale specified in the solicitation or as amended, by one or the following methods: (a) By completing Items 8 and 15, and returning __________ copies of the amendment; (b) By acknowledging receipt of this amendment on each copy of the offer submitted; or (c) By separate letter or telegram which includes a reference to the solicitation and amendment numbers. FAILURE OF YOUR ACKNOWLEDGEMENT TO BE RECEIVED AT THE PLACE DESIGNATED FOR THE RECEIPT OF OFFERS PRIOR TO THE HOUR AND DATE SPECIFIED MAY RESULT IN REJECTION OF YOUR OFFER. If by virtue of this amendment you desire to change an offer already submitted, such change may be made by telegram or letter, provided each telegram or letter makes reference to the solicitation and this amendment, and is received prior to the opening hour and date specified. | ||||||||||||
12. ACCOUNTING AND APPROPRIATION DATA (if required) See Schedule | Net Increase: | $2,812,858.00 | ||||||||||
13. THIS ITEM ONLY APPLIES TO MODIFICATION OF CONTRACTS/ORDERS. IT MODIFIES THE CONTRACT/ORDER NO. AS DESCRIBED IN ITEM 14. | ||||||||||||
CHECK ONE | A. THIS CHANGE ORDER IS ISSUED PURSUANT TO (Specify authority) THE CHANGES SET FORTH IN ITEM 14 ARE MADE IN THE CONTRACT ORDER NO IN ITEM 10A | |||||||||||
B. THE ABOVE NUMBERED CONTRACT/ORDER IS MODIFIED TO REFLECT THE ADMINISTRATIVE CHANGES (such as changes in paying office, appropriation date, etc.) SET FORTH IN ITEM 14, PURSUANT TO THE AUTHORITY OF FAR 43.103(b). | ||||||||||||
C. THIS SUPPLEMENTAL AGREEMENT IS ENTERED INTO PURSUANT TO AUTHORITY OF | ||||||||||||
X | D. OTHER (Specify type of modification and authority) Bilateral: Mutual Agreement of the Parties. | |||||||||||
E. IMPORTANT: Contractor ¨ is not. ý is required to sign this document and return 0 copies to the issuing office. | ||||||||||||
14. DESCRIPTION OF AMENDMENT/MODIFICATION (Organized by UCF section headings, including solicitation/contract subject matter where feasible) Tax ID Number: 33-0903395 DUNS Number: 121785997 A. The purpose of this modification is to incorporate the following changes into the contract: 1. The purpose of this modification is for the Government and the Contractor to bilaterally modify the Statement of Work Requirements for Option 2 CLIN 0003 and CLIN 0004 for the purposes of 1. Adding within scope changes to the Statement of Work for Option 2 [...***...] This within scope change to Option 2 CLIN 0003 is necessary for the full completion of Option 2 CLIN 0003 2. Continued ... Except as provided herein, all terms and conditions of the document referenced in Item 9A or 10A, as heretofore changed, remains unchanged and in full force and effect. | ||||||||||||
15A. NAME AND TITLE OF SIGNER (Type or print) Timothy W. Trost, SVP & CFO | 16A. NAME AND TITLE OF CONTRACTING OFFICER (Type or print) ETHAN J. MUELLER | |||||||||||
15B. CONTRACTOR/OFFEROR /s/ Timothy W. Trost (Signature of person authorized to sign) | 15C. DATE SIGNED 12/21/17 | 16B. UNITED STATES OF AMERICA /s/ Ethan J. Mueller (Signature of person authorized to sign) | 16C. DATE SIGNED 12/21/17 |
CONTINUATION SHEET | REFERENCE NO. OF DOCUMENT BEING CONTINUED HHSO100201100013C/0047 | PAGE OF | ||||||
2 | 18 | |||||||
NAME OF OFFEROR OR CONTRACTOR CHIMERIX, INC. 1377270 | ||||||||
ITEM NO. (A) | SUPPLIES/SERVICES (B) | QUANTITY (C) | UNIT (D) | UNIT PRICE (E) | AMOUNT (F) | |||
[...***...] 2. In addition, the purpose of this bilateral modification is to also add additional cost growth to Option 2 CLIN 0003 Only in order to complete existing within scope activities under Option 2 CLIN 0003 Only. 3. As a result, the addition of these within scope tasks and the cost growth to Option 2/OLIN 0003 under Contract Number HHSO100201100013C results in Contract Line Item Number (CLIN) 0003 being changed as follows: Total Estimated Cost: From [...***...] By $3,912,544.00 To [...***...]. Total Fixed Fee: From [...***...] By $178,633.00 To [...***...]. Total Estimated Cost Plus Fixed Fee: From [...***...] By $4,091,177.00 To [...***...]. 4. As a result, the descope to CLIN 0004 under Contract Number HHSO100201100013C results in Contract Line Item Number (CLIN) 0004 being changed as follows: Total Estimated Cost: From [...***...] By $1,194,731.00 To [...***...]. Total Fixed Fee: From [...***...] By $83,588.00 To [...***...] Total Estimated Cost Plus Fixed Fee: From [...***...] By $1,278,319.00 To [...***...]. 5. This modification also results a change in the total amount of the contract from [...***...] by $2,812,858.00 to [...***...] as well as the following: Total Estimated Cost of the Contract: From [...***...] By $2,717,813.30 To [...***...]. Total Fixed Fee: From [...***...] By $95,045.00 To [...***...]. Total Estimated Cost Plus Fixed Fee of the Contract: From [...***...] By $2,812,858.00 To [...***...]. 6. This modification hereby results in a increase in the total amount of the contract from [...***...] by $2,812,858.00 to [...***...]. 7. Block 15G of the SF 26, the amount of $66,637,061.23 shall be changed to $69,449,919.23. 8. Also in Block 14 of the SF 26, the following CAN Number is added as follows: Appropriation Year: 2018; Object Class: 25106; CAN# 1992018 $4,091,177.00 9. The Government and the Contractor bilaterally modify Attachment 1, Statement of Continued ... |
CONTINUATION SHEET | REFERENCE NO. OF DOCUMENT BEING CONTINUED HHSO100201100013C/0047 | PAGE OF | ||||||
3 | 18 | |||||||
NAME OF OFFEROR OR CONTRACTOR CHIMERIX, INC. 1377270 | ||||||||
ITEM NO. (A) | SUPPLIES/SERVICES (B) | QUANTITY (C) | UNIT (D) | UNIT PRICE (E) | AMOUNT (F) | |||
Work dated 11 September 2015, under PART III, LIST OF DOCUMENTS, EXHIBITS AND OTHER ATTACHMENTS, SECTION J - LIST OF ATTACHMENTS for the purposes of incorporating within scope changes to Option 2 CLIN 0003 and the descope deletions under CLIN 0004 and per recent FDA guidance. As such, Attachment 1, Statement of Work dated 11 September 2015, under PART III, LIST OF DOCUMENTS, EXHIBITS AND OTHER ATTACHMENTS, SECTION J - LIST OF ATTACHMENTS is hereby deleted and replaced with the attached Statement of Work dated 20 October 2017 (14 Pages attached herein). The addition efforts that are added to Option 2 CLIN 0003 that involve clinical human trials/studies and non-clinical animal studies cannot be performed until the receipt and approval of all required Protocols by BARDA inclusive of all IRB, OHRP approvals and any required Ethics Approvals for any clinical trials/studies and any required approved OLAW Assurances and IIA approvals from OLAW for any non clinical animal studies. 10. Under WBS Milestones/Deliverables and Technical Deliverables and Technical Deliverables and Contract Milestones and Go/No Go Decision Gates dated 11 September 2015 under Article F.2. Deliverables, under Milestone 19, 4.3.3/5.3.2 for the ECTV Pivotal Study under CLIN 0004 is hereby deleted. 11. The period of performance for Option 2/CLIN 0003 of Contract Number HHSO100201100013C ONLY is hereby changed from 1 September 2014 through 31 December 2017 to 1 September 2014 through 30 September 2018, at no additional cost to the Government. The total amount and scope of Option 2/CLIN 0003 of Contract Number HHSO100201100013C remains unchanged. 12. The period of performance for CLIN 0004 of Contract Number HHSO100201100013C ONLY is hereby changed from 11 September 2015 through 31 December 2017 to 11 September 2015 through 30 September 2018, at no additional cost to the Government. The total amount and scope of CLIN 0004 of Contract Number HHSO100201100013C remains unchanged. 13. The total amount, scope and period of performance of all other CLINs that are currently being performed under the contract remain unchanged. This modification does not exercise any unexercised Option CLINs under the contract and does not authorize any performance of efforts under any unexercised Option CLINs under the contract. In addition, the total amount, scope and period of performance of all unexercised Option CLINs under the contract remain unchanged. This modification also confirms that all activities under the base period of performance CLIN 0001 were completed as of 31 May 2013 and confirms that all activities under the Option 1/CLIN 0002 period of performance were completed as of 30 April 2015. B. This is a bilateral modification. All other terms and conditions of Contract Number HHSO100201100013C remain unchanged. Delivery Location Code: HHS HHS Continued ... |
CONTINUATION SHEET | REFERENCE NO. OF DOCUMENT BEING CONTINUED HHSO100201100013C/0047 | PAGE OF | ||||||
4 | 18 | |||||||
NAME OF OFFEROR OR CONTRACTOR CHIMERIX, INC. 1377270 | ||||||||
ITEM NO. (A) | SUPPLIES/SERVICES (B) | QUANTITY (C) | UNIT (D) | UNIT PRICE (E) | AMOUNT (F) | |||
3 4 | 200 Independence Avenue, SW Washington DC 20201 US FOB: Destination Period of Performance: 02/16/2011 to 09/30/2018 Change – Item 3 to read as follows (amount shown is the obligated amount) : [...***...] Reports and Other Data Deliverables. Delivery: 11/30/2015 Amount: $16,951,226.00 Accounting Info: 2014.1992003.25106 Appr. Yr.: 2014 CAN: 1992003 Object Class: 25106 Funded: $0.00 Delivery: 06/30/2017 Amount: $535,016.00 Accounting Info: 2016.1992016.25103 Appr. Yr.: 2016 CAN: 1992016 Object Class: 25103 Funded: $0.00 Delivery: 09/30/2018 Amount: $4,091,177.00 Accounting Info: 2018.1992018.25106 Appr. Yr.: 2018 CAN: 1992018 Object Class: 25106 Funded: $4,091,177.00 Change Item 4 to read as follows (amount shown is the obligated amount) : [...***...]. -1,278,319.00 Reports and Other Data Deliverables. Delivery: 09/30/2018 Accounting Info: 2015.1992015.25103 Appr. Yr.: 2015 CAN: 1992015 Object Class: 25103 Funded: -$1,278,319.00 |
1. | PREAMBLE |
I. | [...***...] |
II. | [...***...] |
III. | [...***...] |
IV. | [...***...] |
V. | [...***...] |
2. | PHASE I: [...***...] |
2.1.1 | The overall management, integration and coordination of all contract activities, including a technical and administrative infrastructure to ensure the efficient planning, initiation, implementation, and direction of all contract activities; |
2.1.2 | A Principal Investigator (PI) responsible for project management, communication, tracking, monitoring and reporting on status and progress, and modification to the project requirements and timelines, including projects undertaken by subcontractors; The contract deliverables list (reference), identifies all contract deliverables and reporting requirements for this contract. |
2.1.3 | Project Manager(s) with responsibility for monitoring and tracking day-to-day progress and timelines, coordinating communication and project activities; costs incurred; and program management; The contract deliverables list (reference), identifies all contract deliverables and reporting requirements for this contract. |
2.1.4 | A BARDA Liaison with responsibility for effective communication with the Project Officer and Contracting Officer. |
2.1.5 | Administrative and legal staff to provide development of compliant subcontracts, consulting, and other legal agreements, and ensure timely acquisition of all proprietary rights, including IP rights, and reporting all inventions made in the performance of the project. |
2.1.6 | Administrative staff with responsibility for financial management and reporting on all activities conducted by the Contractor and any subcontractors. |
2.1.7 | Contract Review Meetings. |
2.1.7.1 | The Contractor shall participate in regular meetings to coordinate and oversee the contract effort as directed by the Contracting and Project Officers. Such meetings may include, but are not limited to, meeting of the Contractors and subcontractors to discuss clinical manufacturing progress, product development, product assay development, scale up manufacturing development, clinical sample assays development, preclinical/clinical study designs and regulatory issues; meetings with individual contractors and other HHS officials to discuss the technical, regulatory, and ethical aspects of the program; and meeting with technical consultants to discuss technical data provided by the Contractor. |
2.1.7.2 | The Contractor shall participate in teleconferences every two weeks between the Contractor and subcontractors and BARDA to review technical progress. Teleconferences or additional face-to-face meetings shall be more frequent at the request of BARDA. |
2.1.8 | Integrated Master Schedule |
2.1.8.1 | Within 30 calendar days of the effective date of the contract, the Contractor shall submit a first draft of an updated Integrated Master Schedule in a format agreed upon by BARDA to the Project Officer and the Contracting Officer for review and comment. The Integrated Master Schedule shall be incorporated into the contract, and will be used to monitor performance of the contract. Contractor shall include the key milestones and Go/No Go decision gates. The IMS for the period of performance will be mutually agreed upon at the PMBR |
2.1.9 | Integrated Master Plan |
2.1.9.1 | Work Breakdown Structure: The Contractor shall utilize a WBS template agreed upon by BARDA for reporting on the contact. The Contractor shall expand and delineate the Contract Work Breakdown Structure (CWBS) to a level agreed upon by BARDA as part of their Integrated Master Plan for contract reporting. The CWBS shall be discernable and consistent. BARDA may require Contractor to furnish WBS data at the work package level or at a lower level if there is significant complexity and risk associated with the task. |
2.1.9.2 | GO/ NO-GO Decision Gates: The Integrated Master Plan outlines key milestones with "Go/No Go" decision criteria (entrance and exit criteria for each phase of the project). The project plan should include, but not be limited to, milestones in manufacturing, non-clinical and clinical studies, and regulatory submissions. |
2.1.9.3 | Earned Value Management System Plan: Subject to the requirements under HHSAR Clause 352.234-4, the Contractor shall use principles of Earned Value Management System (EVMS) in the management of this contract. The Seven Principles are: |
II. | Break down the program work scope into finite pieces that can be assigned to a responsible person or organization for control of technical, schedule, and cost objectives. |
III. | Integrate program work scope, schedule, and cost objectives into a performance measurement baseline plan against which accomplishments may be measured. Control Changes to the baseline. |
IV. | Use actual cost incurred and recorded in accomplishing the work performed. |
V. | Objectively assess accomplishments at the work performance level. |
VI. | Analyze significant variances from the plan, forecast impacts, and prepare an estimate at completion based on performance to date and work to be performed. |
VII. | Use earned value information in the company's management processes. |
2.1.10 | Decision Gate Reporting: On completion of a stage of the product development, as defined in the agreed upon Integrated Master Schedule and Integrated Master Plan, the Contractor shall prepare and submit to the Project Officer and the Contracting Officer a Decision Gate Report that contains (i) sufficient detail, documentation and analysis to support successful completion of the stage according to the predetermined qualitative and quantitative criteria that were established for Go/No Go decision making; and (ii) a description of the next stage of product development to be initiated and a request for approval to proceed to the next stage of product development. |
2.1.11 | Risk Management Plan: The Contractor shall develop a risk management plan within 90 days of contract award highlighting potential problems and/or issues that may arise during the life of the contract, their impact on cost, schedule and performance, and appropriate remediation plans. This plan should reference relevant WBS elements where appropriate. Updates to this plan shall be included every three months (quarterly) in the monthly Project Status Report. |
2.1.12 | Performance Measurement Baseline Review (PMBR): The Contractor shall submit a plan for a PMBR to occur within 90 days of contract award. At the PMBR, the Contractor and BARDA shall mutually agree upon the budget, schedule and technical plan baselines (Performance Measurement Baseline). These baselines shall be the basis for monitoring and reporting progress throughout the life of the contract. The PMBR is conducted to achieve confidence that the baselines accurately capture the entire technical scope of work, are consistent with contract schedule requirements, are reasonably and logically planned, and have adequate resources assigned. The goals of the PMBR are as FOLLOWS: |
I. | Jointly assess areas such as the Contractor's planning for complete coverage of the SOW, logical scheduling of the work activities, adequate resources, and identification of inherent risks |
II. | Confirm the integrity of the Performance Measurement Baseline (PMB) |
III. | Foster the use of EVM as a means of communication |
IV. | Provide confidence in the validity of Contractor reporting |
V. | Identify risks associated with the PMB |
VI. | Present any revised PMBs for mutual agreement |
VII. | Present an Integrated Master Schedule: The Contractor shall deliver an initial program level Integrated Master Schedule (IMS) that rolls up all time-phased WBS elements down to the activity level. This IMS shall include the dependencies that exist between tasks. This IMS will be agreed to and finalized at the PMBR. DI-MGMT-81650 may be referenced as guidance in creation of the IMS (see http://www.acq.osd.mil/pm/). |
VIII. | Present the Risk Management Plan |
2.1.13 | Deviation Request: During the course of contract performance, in response to a need to change IMS activities as baselined at the PMBR, the Contractor shall submit a Deviation Report. This report shall request a change in the agreed-upon IMS and timelines. This report shall include: (i) discussion of the justification/rationale for the proposed change; (ii) options for addressing the needed changes from the agreed upon timelines, including a cost-benefit analysis of each option; and (iii) recommendations for the preferred option that includes a full analysis and discussion of the effect of the change on the entire product development program, timelines, and budget. |
2.1.14 | Monthly and Annual Reports: The Contractor shall deliver Project Status Reports on a monthly basis. The reports shall address the items below cross referenced to the WBS, SOW, IMS, and EVM: |
I. | Executive summary highlighting the progress, issues, and relevant activities in manufacturing, non-clinical, clinical, and regulatory; |
II. | Progress in meeting contract milestones, detailing the planned progress and actual progress during the reporting period, explaining any differences between the two and corrective steps; |
III. | Updated IMS; |
IV. | Updated EVM; |
V. | Updated Risk Management Plan (Every 3 months); |
VI. | Three month rolling forecast of planned activities; |
VII. | Progress of regulatory submissions; |
VIII. | Estimated and actual expenses; |
2.1.15 | Data Management: The Contractor shall develop and implement data management and quality control systems/procedures, including transmission, storage, confidentiality, and retrieval of all contract data; |
2.1.15.1 | Provide for the statistical design and analysis of data resulting from the research; |
2.1.15.2 | Provide raw data or specific analyses of data generated with contract funding to the Project Officer, upon request. |
2.2.1 | N/A (no scope) |
2.3.1 | Develop and validate [...***...] to lower [...***...]. |
2.3.2 | [...***...]: Conduct [...***...] studies including [...***...] studies, [...***...] studies in [...***...]. |
2.3.3 | [...***...] |
2.3.3.1 | Conduct [...***...study in [...***...]. |
2.3.3.2 | Conduct [...***...] studies including [...***...studies, [...***...] studies including [...***...] CMX-001 and [...***...] in [...***...]. |
2.3.4 | Use of [...***...] as a CMX-001 Surrogate in [...***...] Studies. |
2.3.4.1 | Dose [...***...] with [...***...] to identify the concentration of the [...***...] in [...***...] associated with [...***...] of [...***...]. |
2.3.5 | Scaling of [...***...] to [...***...] by conducting studies with [...***...] to determine [...***...] in [...***...]. |
2.3.6 | [...***...] of CMX001, [...***...] and [...***...] in the [...***...]. |
2.3.7 | Conduct [...***...] experiments to demonstrate [...***...] following effective [...***...] prior to [...***...]. |
2.3.8 | Conduct studies to [...***...] in [...***...]. |
2.3.9 | Conduct CMX001 [...***...] study in [...***...] at a dose of CMX001 equivalent or less than [...***...] with treatment beginning at the [...***...] |
2.4.1 | Measurement of [...***...] levels in [...***...] and correlate the [...***...] levels to studies conducted in [...***...]. |
2.4.2 | Conduct expanded access protocol ([...***...]). |
2.4.3 | Analyze data and provide a Final Report for [...***...] evaluation of CMX001 in patients ([...***...]) |
2.5.1 | Engaging the FDA on a path to support the treatment of smallpox indication with CMX-001 |
2.5.2 | Preparing materials for and requesting, scheduling and participating in all meetings with the FDA, including meetings to review EUA and/or all other data packages; |
2.5.3 | Providing BARDA with (i) the initial draft minutes and final draft minutes of any formal meeting with the FDA; (ii) final minutes of any informal meeting with the FDA; |
2.5.4 | Obtain FDA concurrence on the feasibility of the proposed [...***...]CMX001/CDV/[...***...] in the [...***...], including FDA feedback on [...***...] and review of data for the first [...***...] enrolled in the [...***...] sub-study |
2.5.5 | Develop and submit a revised [...***...] for CMX001 for Treatment of Smallpox, [...***...] for FDA review and comment, and revise the [...***...] as requested by FDA |
2.6.1 | Validation of the [...***...] process: Validation of the process to demonstrate the [...***...] of a [...***...] of acceptable quality will be performed. |
2.6.2 | Validation of the [...***...] process to produce [...***...]: Validation of the process to demonstrate the [...***...] of a [...***...] of acceptable quality will be performed. |
3. | PHASE II: [...***...] |
3.1.1 | Program management scope in BASE year is consistent with program management scope in each option year. |
3.2.1 | N/A (no scope) |
3.3.1 | Quantify [...***...] concentrations in [...***...] from [...***...]. |
3.3.2 | Determine [...***...] for CMX001 [...***...] in [...***...]. |
3.3.3 | Scaling of [...***...] to [...***...] - Review with BARDA and FDA the [...***...] generated to support scaling between [...***...] and [...***...] using [...***...] as well as comparisons of [...***...] in the [...***...]. |
3.3.4 | Determine [...***...] for CMX001 in [...***...] in [...***...]. |
3.3.5 | Conduct [...***...]. |
3.3.6 | Conduct [...***...] and [...***...] of [...***...] |
3.3.7 | Chimerix will provide [...***...] for the [...***...] and [...***...] conducted under the [...***...] |
3.4.1 | N/A (No scope) |
3.5.1 | Engaging the FDA on a path to support the treatment of smallpox indication with CMX001 |
3.5.2 | Generating all necessary documentation for [...***...]. [[...***...]] |
3.5.3 | Preparing materials for and requesting, scheduling and participating in all meetings with the FDA, including meetings to review EUA (if needed) and/or all other data packages; |
3.5.4 | Providing BARDA with (1) the initial draft minutes and final draft minutes of any formal meeting with the FDA relating to the smallpox program; (ii) final draft minutes of any informal meeting with the FDA relating to the smallpox program. |
3.6.1 | N/A (No scope) |
4. | PHASE III: [...***...] |
4.1.1 | Program management scope in BASE year is consistent with program management scope in each option year. |
4.2.1 | N/A (no scope) |
4.3.1 | [...***...] studies: A [...***...] study will be conducted with the [...***...] of CMX001 selected based on the results of the [...***...] and [...***...] studies, [...***...] will be [...***...] to [...***...] beginning at the [...***...] or the FDA agreed upon trigger for treatment. The first [...***...] study will be a [...***...] study of CMX001 in the [...***...] model. A study will be conducted with an [...***...] of CMX001 to determine the [...***...] after observation of the FDA agreed upon trigger for treatment. These studies will include [...***...] and [...***...]. The primary endpoint will be [...***...]. |
4.3.2 | [...***...] study of CMX001 in the [...***...]: The [...***...] study will evaluate the [...***...] of CMX001 at [...***...]. The study will include [...***...] and [...***...] agreed upon with the FDA. The primary endpoint will be [...***...]. A [...***...] study to measure [...***...] in the selected [...***...] will be conducted to confirm the [...***...]. A [...***...] study will be conducted prior to [...***...] in the [...***...] to determine [...***...] and [...***...].. |
4.3.3 | Conduct additional studies, including [...***...], in [...***...] to determine [...***...] and [...***...] for CMX001 at [...***...] |
4.3.4 | Conduct [...***...] of [...***...] |
4.3.5 | Conduct additional studies for [...***...] of [...***...] to be used in [...***...] |
4.3.6 | Conduct additional [...***...] studies using [...***...]. |
4.4.1 | Clinical [...***...] studies to evaluate [...***...] used in previous clinical studies and [...***...] used in previous clinical studies and [...***...]. This study will [...***...] to [...***...] to determine if [...***...] are comparable. |
4.5.1 | Generating all necessary data and preparing documentation for an [...***...] meeting submission to regulatory agencies; |
4.5.2 | Preparing materials for and requesting, scheduling and participating in all meetings with the FDA, including the [...***...] Meeting, meetings to review [...***...], EUA (if needed) and/or all other data packages; |
4.5.3 | Providing BARDA with (i) the initial draft minutes and final draft minutes of any formal meeting with the FDA relating to this Contract; (ii) final draft minutes of any informal meeting with the FDA; |
4.5.4 | Preparing an [...***...] submission for a [...***...] |
4.6.1 | [...***...] in order to [...***...] for registration and clinical trial supplies |
4.6.2 | [...***...]. Validation of the process to demonstrate the [...***...] of a [...***...] of acceptable quality will be performed. |
5. | PHASE IV: [...***...] |
5.1.1 | Program management scope in BASE year is consistent with program management scope in each option year. |
5.2.1 | N/A (no scope) |
5.3.1 | [...***...]. A [...***...] study will be conducted with [...***...] and [...***...] subject to FDA feedback. [...***...] will be randomized to [...***...] beginning at the [...***...or the FDA agreed upon trigger for treatment. These studies will include [...***...] and [...***...]. The primary endpoint will be [...***...]. |
5.4.1 | N/A (No scope) |
5.5.1 | Generating all necessary data and preparing documentation for NDA submissions to regulatory agencies; |
5.5.2 | Preparing materials for and requesting, scheduling and participating in all meetings with the FDA, including meetings to review IND, NDA and/or all other data packages relating to this Contract; |
5.5.3 | Providing BARDA with (i) the initial draft minutes and final draft minutes of any formal meeting with the FDA; (ii) final draft minutes of any informal meeting with the FDA relating to this Contract |
5.6.1 | [...***...]. [...***...] of the process to demonstrate the [...***...] of the [...***...] of acceptable quality will be performed at new manufacturing site either at [...***...] or [...***...]. May include a [...***...] and [...***...], the [...***...] to support the [...***...], and [...***...] of required necessary [...***...] to support [...***...]. |
6. | PHASE V: [...***...] |
6.1.1 | Program management scope in BASE year is consistent with program management scope in each option year. |
6.2.1 | N/A (no scope) |
6.3.1 | [...***...] Studies. This study replicates [...***...] if a larger sample size is necessary to achieve a [...***...] result. |
6.4.1 | Compile [...***...]. A database of [...***...] collected from all CMX001 clinical studies, irrespective of [...***...], will be populated and analyzed in order to support an NDA for smallpox. |
6.5.1 | Generating all necessary data and preparing documentation for NDA submissions to regulatory agencies; |
6.5.2 | Submitting NDA documentation to the FDA in a timely manner, consistent with timelines set out in the contract and by the FDA. |
6.5.3 | Preparing materials for and requesting, scheduling and participating in all meetings with the FDA, including meetings to review IND, EUA and/or all other data packages; |
6.5.4 | Providing BARDA with (i) the initial draft minutes and final draft minutes of any formal meeting with the FDA; (ii) final draft minutes of any informal meeting with the FDA; |
6.6.1 | [...***...]. [...***...] of the process to demonstrate the [...***...] of a [...***...] will be performed. |
7. | Other Items |
7.1.1 | The [...***...] and use of [...***...]; |
7.1.2 | The acquisition, handling, storage and shipment of [...***...], including [...***...] required for working with the [...***...]; |
7.1.3 | The [...***...] of [...***...] under cGMP; |
7.1.3.1 | The design and conduct of [...***...]; and |
7.1.3.2 | The conduct of [...***...] studies to determine [...***...] of [...***...] |
7.1.4 | Design and conduct of [...***...] under GCP. |
AMENDMENT OF SOLICITATION/MODIFICATION OF CONTRACT | 1. CONTRACT ID CODE | PAGE OF PAGES | ||||||||
1 | 3 | |||||||||
2. AMENDMENT/MODIFICATION NO 0048 | 3. EFFECTIVE DATE See Block 16C | 4. REQUISITION/PURCHASE REQ NO N/A | 5. PROJECT NO (if applicable) | |||||||
6. ISSUED BY CODE | ASPR-BARDA | 7. ADMINISTERED BY (if other than line item 6) CODE | ASPR-BARDA02 | |||||||
ASPR-BARDA 200 Independence Ave., S.W. Room 640-G Washington DC 20201 | ASPR-BARDA 330 Independence Ave., SW, Rm G640 Washington DC 20201 | |||||||||
8. NAME AND ADDRESS OF CONTRACTOR (No, street, county, State and ZIP Code) | (x) | 9A AMENDMENT OF SOLICITATION NO. | ||||||||
CHIMERIX, INC. 1377270 CHIMERIX, INC. 2505 MERIDIAN P 2505 MERIDIAN PKWY STE 340 DURHAM NC 277135246 | ||||||||||
9B DATED (SEE ITEM 11) | ||||||||||
X | 10A MODIFICATION OF CONTRACT/ORDER NO HHSO100201100013C | |||||||||
10B DATED (SEE ITEM 13) 02/16/2011 | ||||||||||
CODE 1377270 | FACILITY CODE | |||||||||
11. THIS ITEM ONLY APPLIES TO AMENDMENTS OF SOLICITATIONS | ||||||||||
¨ The above numbered solicitation is amended as set forth in Item 14. The hour and date specified of receipt of Offers ¨ is extended. ¨ is not extended Offers must acknowledge receipt of this amendment prior to the hour end dale specified in the solicitation or as amended, by one or the following methods: (a) By completing Items 8 and 15, and returning __________ copies of the amendment; (b) By acknowledging receipt of this amendment on each copy of the offer submitted; or (c) By separate letter or telegram which includes a reference to the solicitation and amendment numbers. FAILURE OF YOUR ACKNOWLEDGEMENT TO BE RECEIVED AT THE PLACE DESIGNATED FOR THE RECEIPT OF OFFERS PRIOR TO THE HOUR AND DATE SPECIFIED MAY RESULT IN REJECTION OF YOUR OFFER. If by virtue of this amendment you desire to change an offer already submitted, such change may be made by telegram or letter, provided each telegram or letter makes reference to the solicitation and this amendment, and is received prior to the opening hour and date specified. | ||||||||||
12. ACCOUNTING AND APPROPRIATION DATA (if required) N/A | ||||||||||
13. THIS ITEM ONLY APPLIES TO MODIFICATION OF CONTRACTS/ORDERS. IT MODIFIES THE CONTRACT/ORDER NO. AS DESCRIBED IN ITEM 14. | ||||||||||
CHECK ONE | A. THIS CHANGE ORDER IS ISSUED PURSUANT TO (Specify authority) THE CHANGES SET FORTH IN ITEM 14 ARE MADE IN THE CONTRACT ORDER NO IN ITEM 10A | |||||||||
B. THE ABOVE NUMBERED CONTRACT/ORDER IS MODIFIED TO REFLECT THE ADMINISTRATIVE CHANGES (such as changes in paying office, appropriation date, etc.) SET FORTH IN ITEM 14, PURSUANT TO THE AUTHORITY OF FAR 43.103(b). | ||||||||||
C. THIS SUPPLEMENTAL AGREEMENT IS ENTERED INTO PURSUANT TO AUTHORITY OF | ||||||||||
X | D. OTHER (Specify type of modification and authority) Bilateral: Mutual Agreement of the Parties. | |||||||||
E. IMPORTANT: Contractor ¨ is not. ý is required to sign this document and return 0 copies to the issuing office. | ||||||||||
14. DESCRIPTION OF AMENDMENT/MODIFICATION (Organized by UCF section headings, including solicitation/contract subject matter where feasible) Tax ID Number: 33-0903395 DUNS Number: 121785997 A. The purpose of this modification is to incorporate the following changes into the contract: 1. Under Contract Number HHS0100201100013D in SECTION 6 – CONTRACT ADMINISTRATION DATA, under Article G.10. Government Property, the following is hereby added as Paragraph 6. and titled “Disposition Instructions” as follows: 6. Disposition Instructions Continued ... Except as provided herein, all terms and conditions of the document referenced in Item 9A or 10A, as heretofore changed, remains unchanged and in full force and effect. | ||||||||||
15A. NAME AND TITLE OF SIGNER (Type or print) Timothy W. Trost, SVP & CFO | 16A. NAME AND TITLE OF CONTRACTING OFFICER (Type or print) ETHAN J. MUELLER | |||||||||
15B. CONTRACTOR/OFFEROR /s/ Timothy W. Trost (Signature of person authorized to sign) | 15C. DATE SIGNED 12/21/17 | 16B. UNITED STATES OF AMERICA /s/ Ethan J. Mueller (Signature of person authorized to sign) | 16C. DATE SIGNED 12/21/17 |
CONTINUATION SHEET | REFERENCE NO. OF DOCUMENT BEING CONTINUED HHSO100201100013C/0048 | PAGE OF | ||||||
2 | 3 | |||||||
NAME OF OFFEROR OR CONTRACTOR CHIMERIX, INC. 1377270 | ||||||||
ITEM NO. (A) | SUPPLIES/SERVICES (B) | QUANTITY (C) | UNIT (D) | UNIT PRICE (E) | AMOUNT (F) | |||
Title for retain samples for batches CMX001 Tab 100mg nor-film (FC) coated, R&D Formulation (CNX-CTM-029 (200 Tablets, i.e. 20 bottles 10 count) (CMX-CTM-032 (200 Tablets, i.e. 20 bottles 10 count) and stability samples for batches of CMX001 Tab 100mg non-film coated, R&D Formulation (CMX-CTM-029 (2,500 Tablets, i.e. 250 bottles 10 count) (CMX-CTM-032 (3,240 Tablets, i.e. 324 bottles 10 count) Only under Contract Number HHSO100201100013C that are no longer needed by the Government and have no commercial market value will hereby vest with the Contractor and will be destroyed by Chimerix following proper Cgmp destruction procedures Only. 2. In signing this no cost bilateral modification, the Contractor hereby certifies for both Chimerix and any of its subcontractors at any tier that the retain samples for batches of CMX001 Tab 100mg non-film (FC) coated, R&D Formulation (CMX-CTM-029 (200 Tablets, i.e. 20 bottles 10 count) (CMX-CTM-032 (200 Tablets, i.e. 20 bottles 10 count) and stability samples for batches of CMX001 Tab 100mg non-film coated, R&D Formulation (CMX-CTM-029 (2,500 Tablets, i.e. 250 bottles 10 count) (CMX-CTM-032 (3,240 Tablets, i.e. 324 bottles 10 count) Only under Contract Number HHSO100201100013C that are no longer needed by the Government and have no commercial market value that the Government will be turning title over to the Contractor will be destroyed Only and will not be repurposed for use under any efforts nor disposed of, nor destroyed in any methods that are prohibited by any federal, state and local laws and regulations and will not result in any costs being incurred under both Contract Number HHSO100201100013C and under any other U.S. Government contracts and in signing this no cost bilateral modification, the Contractor also hereby certifies for both Chimerix and any of its subcontractors at any tier that the retain samples for batches of CMX001 Tab 100mg non-film (FC) coated, R&D Formulation (CMX-CTM-029 (200 Tablets, i.e. 20 bottles 10 count) (CMX-CTM-032 (200 Tablets, i.e. 20 bottles 10 count) and stability, samples for batches of CMX001 Tab 100mg non-film coated, R&D Formulation (CMX-CTM-029 (2,500 Tablets, i.e. 250 bottles 10 count) (CMX-CTM-032 (3,240 Tablets, i.e. 324 bottles 10 count) Only under Contract Number HHSO100201100013C that are no longer needed by the Government and have no commercial market value that the Government will be turning title over to the Contractor will not be repurposed for the performance of any other efforts that are under the scope of Contract Number HHSO100201100013C nor under any other Government contracts by either Chimerix or any of its subcontractors at any tier and will not result in any costs being incurred under both Contract Number HHSO100201100013C and under any other U.S. Government contracts. 3. In signing this no cost bilateral modification, the Contractor hereby certifies for both Chimerix and any of its subcontractors at any tier that the retain samples for batches of CMX001 Tab 100mg non-film (FC) coated, R&D Formulation (CMX-CTM-029 (200 Tablets, i.e. 20 bottles 10 count) (CMX-CTM-032 (200 Tablets, i.e. 20 bottles 10 count) and stability samples for batches of CMX001 Tab 100mg non-film coated, R&D Formulation (CMX-CTM-029 (2,500 Tablets, i.e. 250 bottles 10 count) (CMX-CTM-032 (3,240 Tablets, i.e. 324 bottles 10 count) Only under Contract Number HHSO100201100013C that are no longer needed by the Government and have no commercial market value that the Government will be turning title over to the Contractor once they are destroyed, Chimerix will send certified documentation to the Contracting Officer that certifies the official destruction of the property. 4. The total amount, scope and period of performance of all other CLINs that are Continued ... |
CONTINUATION SHEET | REFERENCE NO. OF DOCUMENT BEING CONTINUED HHSO100201100013C/0048 | PAGE OF | ||||||
3 | 3 | |||||||
NAME OF OFFEROR OR CONTRACTOR CHIMERIX, INC. 1377270 | ||||||||
ITEM NO. (A) | SUPPLIES/SERVICES (B) | QUANTITY (C) | UNIT (D) | UNIT PRICE (E) | AMOUNT (F) | |||
Currently being performed under the contract remain unchanged. This modification does not exercise any unexercised Option CLINs under the contract and does not authorize any performance of efforts under any unexercised Option CLINs under the contract. In addition, the total amount, scope and period of performance of all unexercised Option CLINs under the contract remain unchanged. This modification also confirms that all activities under the base period of performance CLIN 0001 were completed as of 31 May 2013 and confirms that all activities under the Option 1/CLIN 0002 period of performance were completed as of 30 April 2015. B. This is a no cost bilateral modification. All other terms and conditions of Contract Number HHSO100201100013C remain unchanged. Period of Performance: 02/16/2011 to 09/30/2018 |
AMENDMENT OF SOLICITATION/MODIFICATION OF CONTRACT | 1. CONTRACT ID CODE | PAGE OF PAGES | ||||||||||
1 | 4 | |||||||||||
2. AMENDMENT/MODIFICATION NO 0049 | 3. EFFECTIVE DATE See Block 16C | 4. REQUISITION/PURCHASE REQ NO N/A. | 5. PROJECT NO (if applicable) | |||||||||
6. ISSUED BY CODE | ASPR-BARDA | 7. ADMINISTERED BY (if other than line item 6) CODE | ASPR-BARDA02 | |||||||||
ASPR-BARDA 200 Independence Ave., S.W. Room 640-G Washington DC 20201 | ASPR-BARDA 330 Independence Ave., SW, Rm G640 Washington DC 20201 | |||||||||||
8. NAME AND ADDRESS OF CONTRACTOR (No, street, county, State and ZIP Code) | (x) | 9A AMENDMENT OF SOLICITATION NO. | ||||||||||
CHIMERIX, INC. 1377270 CHIMERIX, INC. 2505 MERIDIAN P 2505 MERIDIAN PKWY STE 340 DURHAM NC 277135246 | ||||||||||||
9B DATED (SEE ITEM 11) | ||||||||||||
x | 10A MODIFICATION OF CONTRACT/ORDER NO HHSO100201100013C | |||||||||||
10B DATED (SEE ITEM 13) 02/16/2011 | ||||||||||||
CODE 1377270 | FACILITY CODE | |||||||||||
11. THIS ITEM ONLY APPLIES TO AMENDMENTS OF SOLICITATIONS | ||||||||||||
¨ The above numbered solicitation is amended as set forth in Item 14. The hour and date specified of receipt of Offers ¨ is extended. ¨ is not extended Offers must acknowledge receipt of this amendment prior to the hour end dale specified in the solicitation or as amended, by one or the following methods: (a) By completing Items 8 and 15, and returning __________ copies of the amendment; (b) By acknowledging receipt of this amendment on each copy of the offer submitted; or (c) By separate letter or telegram which includes a reference to the solicitation and amendment numbers. FAILURE OF YOUR ACKNOWLEDGEMENT TO BE RECEIVED AT THE PLACE DESIGNATED FOR THE RECEIPT OF OFFERS PRIOR TO THE HOUR AND DATE SPECIFIED MAY RESULT IN REJECTION OF YOUR OFFER. If by virtue of this amendment you desire to change an offer already submitted, such change may be made by telegram or letter, provided each telegram or letter makes reference to the solicitation and this amendment, and is received prior to the opening hour and date specified. | ||||||||||||
12. ACCOUNTING AND APPROPRIATION DATA (if required) N/A. | Net Increase: | $2,812,858.00 | ||||||||||
13. THIS ITEM ONLY APPLIES TO MODIFICATION OF CONTRACTS/ORDERS. IT MODIFIES THE CONTRACT/ORDER NO. AS DESCRIBED IN ITEM 14. | ||||||||||||
CHECK ONE | A. THIS CHANGE ORDER IS ISSUED PURSUANT TO (Specify authority) THE CHANGES SET FORTH IN ITEM 14 ARE MADE IN THE CONTRACT ORDER NO IN ITEM 10A | |||||||||||
B. THE ABOVE NUMBERED CONTRACT/ORDER IS MODIFIED TO REFLECT THE ADMINISTRATIVE CHANGES (such as changes in paying office, appropriation date, etc.) SET FORTH IN ITEM 14, PURSUANT TO THE AUTHORITY OF FAR 43.103(b). | ||||||||||||
C. THIS SUPPLEMENTAL AGREEMENT IS ENTERED INTO PURSUANT TO AUTHORITY OF | ||||||||||||
X | D. OTHER (Specify type of modification and authority) Bilateral: Mutual Agreement of the Parties. | |||||||||||
E. IMPORTANT: Contractor ¨ is not. ý is required to sign this document and return 0 copies to the issuing office. | ||||||||||||
14. DESCRIPTION OF AMENDMENT/MODIFICATION (Organized by UCF section headings, including solicitation/contract subject matter where feasible) Tax ID Number: 33-0903395 DUNS Number: 121785997 A. The purpose of this modification is to incorporate the following changes into the contract: 1. Under Contract Number HHSO100201100013C in SECTION G – CONTRACT ADMINISTRATION DATA, under Article G.10. Government Property, the following is hereby added as Paragraph 7. and titled “disposition Instructions” as follows: 7. Disposition Instructions Continued ... Except as provided herein, all terms and conditions of the document referenced in Item 9A or 10A, as heretofore changed, remains unchanged and in full force and effect. | ||||||||||||
15A. NAME AND TITLE OF SIGNER (Type or print) Timothy W. Trost, SVP & CFO | 16A. NAME AND TITLE OF CONTRACTING OFFICER (Type or print) ETHAN J. MUELLER | |||||||||||
15B. CONTRACTOR/OFFEROR /s/ Timothy W. Trost (Signature of person authorized to sign) | 15C. DATE SIGNED 2/26/18 | 16B. UNITED STATES OF AMERICA /s/ Ethan J. Mueller (Signature of person authorized to sign) | 16C. DATE SIGNED 2/27/18 |
CONTINUATION SHEET | REFERENCE NO. OF DOCUMENT BEING CONTINUED HHSO100201100013C/0049 | PAGE OF | ||||||
2 | 4 | |||||||
NAME OF OFFEROR OR CONTRACTOR CHIMERIX, INC. 1377270 | ||||||||
ITEM NO. (A) | SUPPLIES/SERVICES (B) | QUANTITY (C) | UNIT (D) | UNIT PRICE (E) | AMOUNT (F) | |||
Title for [...***...] under Contract Number HHSO100201100013C that are no longer needed by the Government and have no commercial market value will hereby vest with the Contractor. 2. In signing this no cost bilateral modification, the Contractor hereby certifies for both Chimerix and any of its subcontractors at any tier that the [...***...] under Contract Number HHS0100201100013C that are no longer needed by the Government and have no commercial market value that the Government will be turning title over to the Contractor will not be repurposed for use under any efforts in any methods that are prohibited by any federal, state and local laws and regulations and will not result in any costs being incurred under both Contract Number HHS0100201100013C and under any other U.S. Government contracts in effect as of the effective date of this modification and in signing this no cost bilateral modification, the Contractor also hereby certifies for both Chimerix and any of its subcontractors at any tier that the [...***...] under Contract Number HHS0100201100013C that are no longer needed by the Government and have no commercial market value that the Government will be turning title over to the Contractor will not be repurposed for the performance of any other efforts that are under the scope of Contract Number HHS0100201100013C nor under any other U.S. Government contracts in effect as of the effective date of this modification by either Chimerix or any of its subcontractors at any tier any will not result in any costs being incurred under both Contract Number HHSO100201100013C and under any other U.S. Government contracts. 3. As consideration for the transfer of Title for [...***...] from the Government under Contract Number HHSO100201100013C to Chimerix, the Government and Chimerix hereby bilaterally and mutually agree to the following: a. For Option 1 CLIN 0002, for Modification 14, Total Estimated Cost – [...***...], Total Fixed Fee – [...***...] and Total Estimated cost Plus Fixed Fee – [...***...] Only, the following Indirect Cost Ceiling is established for which Chimerix cannot seek reimbursement in excess of the following Indirect Cost Ceiling: [...***...] b. For Option 1 CLIN 0002 Cost Growth, for Modification 16, Total Estimated Cost – [...***...] Only, the following Indirect Cost Ceiling is established for which Chimerix cannot seek reimbursement in excess of the following Indirect Cost Ceiling: [...***...] c. For Option 2 CLIN 0003, for Modification 19, Total Estimated Cost – [...***...], Total Fixed Fee – [...***...] and Total Estimated Cost Plus Fixed Fee – [...***...] Only, the following Indirect Cost Ceiling is established for which Chimerix cannot seek reimbursement in excess of the following Indirect Cost Ceiling and within the Total Estimated Cost of [...***...] Only: [...***...] d. For Option 2 CLIN 0003 Cost Growth, for Modification 34, Total Estimated Cost – Continued ... |
CONTINUATION SHEET | REFERENCE NO. OF DOCUMENT BEING CONTINUED HHSO100201100013C/0049 | PAGE OF | ||||||
3 | 4 | |||||||
NAME OF OFFEROR OR CONTRACTOR CHIMERIX, INC. 1377270 | ||||||||
ITEM NO. (A) | SUPPLIES/SERVICES (B) | QUANTITY (C) | UNIT (D) | UNIT PRICE (E) | AMOUNT (F) | |||
[...***...] Only, the following Indirect Cost Ceiling is established for which Chimerix cannot seek reimbursement in excess of the following Indirect Cost Ceiling and within the Total Estimated Cost of [...***...] Only: [...***...] e. For Option 2 CLIN 0003, supplement for Modification 47, Total Estimated Cost – [...***...], Total Fixed Fee – [...***...] and Total Estimated Cost Plus Fixed Fee – [...***...] Only, the following Indirect Cost Ceiling Rates are established for which Chimerix cannot seek reimbursement in excess of the following indirect Cost Ceiling Rates: [...***...]% Fringe, [...***...]% G&A f. For CLIN 0004, for Modification 47, Total Estimated Cost – [...***...], Total Fixed Fee – [...***...] and Total Estimated Cost Plus Fixed Fee – [...***...] Only, the following Indirect Cost Ceiling is established for which Chimerix cannot seek reimbursement in excess of the following Indirect Cost Ceiling and within the Total Estimated Cost of [...***...] Only: [...***...] g. For any Indirect Rates for Calendar Years 2018 and beyond under this contract, the following Indirect Rates are established as Indirect Cost Ceiling Rates for which Chimerix cannot seek reimbursement in excess of the following Indirect Cost Ceiling Rates; [...***...]% Fringe, [...***...]% G&A h. In signing this no cost bilateral modification, Chimerix hereby certifies that they have received as of the executed date of this modification full payment under both CLIN 0001 and CLIN 0002 (Including any supplemental amounts) for all indirect expenses (both forward billing indirect expenses and retroactive billing indirect expenses) and will seek no further payment/reimbursement from the Government for indirect expenses under both CLIN 0001 and CLIN 0002 (Including any supplemental amounts). 4. The total amount, scope and period of performance of all other CLINs that are currently being performed under the contract remain unchanged. This modification does not exercise any unexercised Option CLINs under the contract and does not authorize any performance of efforts under any unexercised Option CLINs under the contract. In addition, the total amount, scope an period of performance of all unexercised Option CLINs under the contract remain unchanged. This modification also confirms that all activities under the base period of performance CLIN 0001 were completed as of 31 May 2013 and confirms that all activities under the Option 1/CLIN 0002 period of performance were completed as of 30 April 2015. B. This is a no cost bilateral modification. All other terms and conditions of Contract Number HHS0100201100013C remain unchanged. Continued . . . |
CONTINUATION SHEET | REFERENCE NO. OF DOCUMENT BEING CONTINUED HHSO100201100013C/0049 | PAGE OF | ||||||
4 | 4 | |||||||
NAME OF OFFEROR OR CONTRACTOR CHIMERIX, INC. 1377270 | ||||||||
ITEM NO. (A) | SUPPLIES/SERVICES (B) | QUANTITY (C) | UNIT (D) | UNIT PRICE (E) | AMOUNT (F) | |||
Period of Performance: 02/16/2011 to 09/30/2018 |
Months | Annual Base Rent Rate Per Sq. Ft. | Annual Base Rent | Monthly Installment of Base Rent |
August 1, 2018 – July 31, 2019 | $17.50 | $138,687.50 | $11,557.29 |
August 1, 2019 – July 31, 2020 | $18.03 | $142,887.75 | $11,907.32 |
August 1, 2020 – July 31, 2021 | $18.57 | 147.167.25 | $12,263.94 |
2. | Renewal Option. |
TENANT: | CHIMERIX, INC., |
1. | Registration Statement (Form S-8 No. 333-187860) pertaining to the 2002 Equity Incentive Plan, 2012 Equity Incentive Plan, 2013 Equity Incentive Plan and 2013 Employee Stock Purchase Plan of Chimerix, Inc., |
2. | Registration Statement (Form S-8 Nos. 333-194408, 333-202582, 333-209802 and 333-216396) pertaining to the 2013 Equity Incentive Plan and 2013 Employee Stock Purchase Plan of Chimerix, Inc., and |
3. | Registration Statement (Form S-3 No. 333-221412) of Chimerix, Inc.; |
/s/ Ernst & Young LLP | ||
Raleigh, North Carolina | ||
March 1, 2018 |
Date: | March 1, 2018 | /s/ M. Michelle Berrey | |
M. Michelle Berrey, MD, MPH | |||
President & Chief Executive Officer |
Date: | March 1, 2018 | /s/ Timothy W. Trost | |
Timothy W. Trost Senior Vice President, Chief Financial Officer and Corporate Secretary |
Date: | March 1, 2018 | /s/ M. Michelle Berrey | |
M. Michelle Berrey, MD, MPH | |||
President & Chief Executive Officer |
Date: | March 1, 2018 | /s/ Timothy W. Trost | |
Timothy W. Trost Senior Vice President, Chief Financial Officer and Corporate Secretary |
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Document And Entity Information - USD ($) |
12 Months Ended | ||
---|---|---|---|
Dec. 31, 2017 |
Feb. 22, 2018 |
Jun. 30, 2017 |
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Document And Entity Information [Abstract] | |||
Document Type | 10-K | ||
Amendment Flag | false | ||
Document Period End Date | Dec. 31, 2017 | ||
Document Fiscal Year Focus | 2017 | ||
Document Fiscal Period Focus | FY | ||
Entity Registrant Name | CHIMERIX INC | ||
Entity Central Index Key | 0001117480 | ||
Entity Voluntary Filers | No | ||
Entity Well-known Seasoned Issuer | No | ||
Entity Current Reporting Status | Yes | ||
Current Fiscal Year End Date | --12-31 | ||
Entity Filer Category | Accelerated Filer | ||
Entity Public Float | $ 151,017,173 | ||
Entity Common Stock, Shares Outstanding | 47,652,332 |
Consolidated Balance Sheets (Parenthetical) - $ / shares |
Dec. 31, 2017 |
Dec. 31, 2016 |
---|---|---|
Statement of Financial Position [Abstract] | ||
Preferred stock, par value (in USD per share) | $ 0.001 | $ 0.001 |
Preferred stock, shares authorized | 10,000,000 | 10,000,000 |
Preferred stock, shares issued | 0 | 0 |
Preferred stock, shares outstanding | 0 | 0 |
Common stock, par value (in USD per share) | $ 0.001 | $ 0.001 |
Common stock, shares authorized (in shares) | 200,000,000 | 200,000,000 |
Common stock, shares, issued (in shares) | 47,505,532 | 46,522,475 |
Common stock, shares, outstanding (in shares) | 47,505,532 | 46,522,475 |
Consolidated Statements of Operations and Comprehensive Loss - USD ($) |
12 Months Ended | ||
---|---|---|---|
Dec. 31, 2017 |
Dec. 31, 2016 |
Dec. 31, 2015 |
|
Revenues: | |||
Contract revenue | $ 4,494,000 | $ 5,702,000 | $ 9,214,000 |
Collaboration and licensing revenue | 0 | 0 | 1,548,000 |
Total revenues | 4,494,000 | 5,702,000 | 10,762,000 |
Operating expenses: | |||
Research and development | 49,448,000 | 58,647,000 | 97,717,000 |
General and administrative | 27,148,000 | 25,007,000 | 31,296,000 |
Total operating expenses | 76,596,000 | 83,654,000 | 129,013,000 |
Loss from operations | (72,102,000) | (77,952,000) | (118,251,000) |
Other (expense) income: | |||
Other-than-temporary impairment of investment | (1,160,000) | 0 | 0 |
Interest income, net | 2,278,000 | 1,562,000 | 879,000 |
Net loss | (70,984,000) | (76,390,000) | (117,372,000) |
Other comprehensive loss: | |||
Unrealized (loss) gain on investments, net | (523,000) | 324,000 | (799,000) |
Comprehensive loss | $ (71,507,000) | $ (76,066,000) | $ (118,171,000) |
Per share information: | |||
Net loss, basic and diluted (in USD per share) | $ (1.51) | $ (1.65) | $ (2.67) |
Weighted-average shares outstanding, basic and diluted (in shares) | 46,963,430 | 46,267,064 | 43,878,326 |
Consolidated Statements of Stockholders' Equity (Deficit) (Parenthetical) $ in Thousands |
12 Months Ended |
---|---|
Dec. 31, 2015
USD ($)
$ / shares
shares
| |
Stock issuance costs | $ 0 |
Common Stock Offering, June 16, 2015 | |
New issues of stock during period (in shares) | shares | 4,341,250 |
Offering price per share (in USD per share) | $ / shares | $ 39.75 |
Stock issuance costs | $ 10,685 |
The Business and Summary of Significant Accounting Policies |
12 Months Ended | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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Accounting Policies [Abstract] | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
The Business and Summary of Significant Accounting Policies | The Business and Summary of Significant Accounting Policies Description of Business Chimerix, Inc. (the Company) is a biopharmaceutical company committed to discovering, developing and commercializing medicines that improve outcomes for immunocompromised patients. The Company was founded in 2000 based on the promise of our proprietary lipid conjugate technology to unlock the potential of some of the most broad-spectrum antivirals by enhancing their antiviral activity and safety profiles in convenient dosing regimens. The Company's lead compound, brincidofovir, is in development as an oral and intravenous (IV) formulation for the prevention and treatment of DNA viruses, including smallpox, adenoviruses, and the human herpesviruses. The Company is also advancing the development of CMX521 for the treatment and prevention of norovirus. In addition, the Company has an active discovery program focusing on viral targets for which limited or no therapies are currently available. Basis of Presentation The consolidated financial statements include the accounts of the Company, and its wholly owned subsidiaries. The accompanying consolidated financial statements have been prepared in accordance with accounting principles generally accepted in the United States of America (GAAP). The preparation of the Company’s consolidated financial statements requires estimates and assumptions that affect the reported amounts of assets, liabilities, revenues and expenses, and the disclosure of contingent assets and liabilities in the consolidated financial statements and accompanying notes. Although these estimates are based on knowledge of current events and actions the Company may undertake in the future, actual results may ultimately differ from these estimates and assumptions. Reclassifications Certain prior period amounts in the accompanying consolidated financial statements have been reclassified to conform to the current year presentation. These reclassifications had no effect on previously reported net income or stockholders' equity (deficit). Cash and Cash Equivalents The Company considers any highly liquid instrument with an original maturity of three months or less at acquisition to be a cash equivalent. Cash equivalents consist of money market funds and commercial paper. Investments Investments consist primarily of brokered certificates of deposit, U.S. Treasury securities and stock of a U.S. corporation. The Company invests in high-credit quality investments in accordance with its investment policy which minimizes the probability of loss. Available-for-sale securities are carried at fair value as determined by quoted market prices, with the unrealized gains and losses, net of tax, reported as a separate component of stockholders equity. Realized gains and losses are determined using the specific identification method and transactions are recorded on a settlement date basis in interest income or expense, net. Investments with original maturities beyond three months at the date of purchase and which mature on, or less than twelve months from, the balance sheet date are classified as short-term. Investments with a maturity beyond twelve months from the balance sheet date are classified as long-term. The Company periodically reviews available-for-sale securities for other-than-temporary declines in fair value below the cost basis and whenever events or changes in circumstances indicate that the carrying amount of an asset may not be recoverable. The Company evaluates, among other things, the duration and extent to which the fair value of a security is less than its cost; the financial condition of the issuer and any changes thereto; and the Company’s intent to sell, or whether it will more likely than not be required to sell, the security before recovery of its amortized cost basis. The Company does not intend to sell, and is not likely to be required to sell, the available-for-sale securities in an unrealized loss position before recovery of the amortized cost bases of the securities, which may be maturity. Any such declines in value judged to be other-than-temporary on available-for-sale securities are reported in other-than-temporary impairment of investment. For the year ended December 31, 2017, the Company determined the decline in value for its investment in ContraVir Pharmaceuticals common stock to be other-than temporary. As such, during the fourth quarter of 2017, the Company reclassified a loss of $1.2 million from accumulated other comprehensive loss, net in the Consolidated Balance Sheets to other-than-temporary impairment of investment in the Consolidated Statements of Operations and Comprehensive Loss. There were no such declines in value for the years ended December 31, 2016 and 2015. The Company recognizes interest income on an accrual basis in interest income, net in the Consolidated Statements of Operations and Comprehensive Loss. Concentration of Credit Risk Financial instruments that potentially subject the Company to concentrations of credit risk consist of cash, cash equivalents, short-term investments, long-term investments and accounts receivable. The Company is exposed to credit risk, subject to federal deposit insurance, in the event of default by the financial institutions holding its cash and cash equivalents to the extent of amounts recorded on the balance sheets. Accounts receivable represent amounts due from an agency of the federal government. Accounts Receivable Accounts receivable at December 31, 2017 and December 31, 2016 consisted of amounts billed under the Company’s contract with the Biomedical Advanced Research and Development Authority (BARDA). Receivables under the BARDA contract are recorded as qualifying research activities are conducted and invoices from the Company’s vendors are received. The Company carries its accounts receivable at cost less an allowance for doubtful accounts. On a periodic basis, the Company evaluates its accounts receivable and establishes an allowance based on its history of collections and write-offs and the current status of all receivables. The Company does not accrue interest on trade receivables. If accounts become uncollectible, they will be written off through a charge to the allowance for doubtful accounts. The Company has not recorded a charge to allowance for doubtful accounts as management believes all receivables are fully collectible. Fair Value of Financial Instruments The carrying amounts of certain financial instruments, including accounts receivable, accounts payable and accrued expenses approximate their fair values due to the short-term nature of such instruments. For assets and liabilities recorded at fair value, it is the Company’s policy to maximize the use of observable inputs and minimize the use of unobservable inputs when developing fair value measurements, in accordance with the fair value hierarchy. Fair value measurements for assets and liabilities where there exists limited or no observable market data are based primarily upon estimates and are often calculated based on the economic and competitive environment, the characteristics of the asset or liability and other factors. Therefore, fair value measurements cannot be determined with precision and may not be realized in an actual sale or immediate settlement of the asset or liability. Additionally, there may be inherent weaknesses in any calculation technique and changes in the underlying assumptions used, including discount rates and estimates of future cash flows, could significantly affect the calculated current or future fair values. The Company utilizes fair value measurements to record fair value adjustments to certain assets and liabilities and to determine fair value disclosures. The Company groups assets and liabilities at fair value in three levels, based on the markets in which the assets and liabilities are traded and the reliability of the assumptions used to determine fair value. An adjustment to the pricing method used within either Level 1 or Level 2 inputs could generate a fair value measurement that effectively falls in a lower level in the hierarchy. These levels are:
The determination of where an asset or liability falls in the hierarchy requires significant judgment. The Company evaluates hierarchy disclosures and, based on various factors, it is possible that an asset or liability may be classified differently from period to period. However, the Company expects that changes in classification between levels will be rare. There were no transfers between Level 1 and Level 2 or transfers to or from Level 3 during the year ended December 31, 2017. When the 18 month restriction on selling the Company's investment in ContraVir Pharmaceuticals ended on June 17, 2016, the investment was transferred from Level 3 to Level 2 as the fair value was based on quoted prices for similar assets and there were no significant unobservable inputs. The Company's investment in ContraVir Pharmaceuticals transferred from Level 2 to Level 1 when the Company converted its investment in Series B Preferred shares into common stock in September 2016. At December 31, 2017 and 2016, the Company had cash equivalents, consisting of money market funds, and short-term and long-term investments consisting of U.S. Treasury securities, whose value is based on using quoted market prices. Accordingly, these securities are classified as Level 1. At December 31, 2017, the Company had cash equivalents, consisting of commercial paper, and at December 31, 2016, the Company had cash equivalents consisting of commercial paper, and short-term investments comprised of brokered certificates of deposits, for which quoted prices are not available that are valued using independent pricing models or other model-based valuation techniques such as the present value of future cash flows, adjusted for the security’s credit rating, prepayment assumptions and other factors such as credit loss assumptions. Accordingly, these securities are classified as Level 2. At December 31, 2015, the Company's preferred stock investment in ContraVir Pharmaceuticals was categorized as Level 3 as there were significant unobservable inputs. The valuation of the investment at December 31, 2015 was calculated on an as if converted to common share basis with a discount for lack of marketability applied due to the 18 month restriction from the date of the investment on selling the converted common shares, which ended on June 17, 2016. An option pricing model was used to determine the discount for lack of marketability of 10% at December 31, 2015. The key unobservable inputs used in the option pricing model at December 31, 2015 were (i) exercise price - $1.54, (ii) dividend yield - 0%, (iii) expected holding period - 0.46 years, (iv) risk-free rate - 0.44%, and (v) volatility - 75%. On September 30, 2016, the Company converted its preferred stock investment in ContraVir into 1,071,429 shares of ContraVir common stock, which was categorized as a Level 1 asset and valued based on ContraVir's common stock value. The Company evaluates, among other things, the duration and extent to which the fair value of a security is less than its cost; the financial condition of the issuer and any changes thereto; and the Company’s intent to sell, or whether it will more likely than not be required to sell, the security before recovery of its market value. For the years ended December 31, 2016 and 2015, the Company did not intend to sell, and was not more likely than not to be required to sell, its investment in ContraVir before recovery of its market value, therefore the changes in the fair value of ContraVir common shares was recorded to unrealized (loss) gain on investments, net in the Consolidated Statements of Operations and Comprehensive Loss. There was no material re-measurement to fair value of financial assets and liabilities that are not measured at fair value on a recurring basis. For additional information regarding the Company's investments, please refer to Note 2, "Investments." Below is a table that presents information about certain assets measured at fair value on a recurring basis (in thousands):
Below is a table that presents a reconciliation of the beginning and ending balances of assets and liabilities measured at fair value on a recurring basis using significant unobservable inputs (Level 3) (in thousands):
Prepaid Expenses and Other Current Assets Prepaid expenses and other current assets consisted of the following (in thousands):
Property and Equipment Property and equipment are stated at cost, less accumulated depreciation. Depreciation is determined on a straight-line basis over the estimated useful lives of the assets, which generally range from three to five years. Leasehold improvements are amortized over the shorter of the useful life of the asset or the term of the related lease. Maintenance and repairs are charged against expense as incurred. Impairment of Long-Lived Assets The Company evaluates long-lived assets for impairment whenever events or changes in circumstances indicate that the carrying value of an asset may not be recoverable. If the estimated future cash flows (undiscounted and without interest charges) from the use of an asset are less than the carrying value, a write-down would be recorded to reduce the related asset to its estimated fair value. To date, no such write-downs have occurred. Deferred Lease Obligations The Company recognizes rent expense on a straight-line basis over the non-cancelable term of its operating lease and records the difference between cash rent payments and the recognition of rent expense as a deferred rent liability. The Company also records landlord-funded lease incentives, such as reimbursable leasehold improvements, as a deferred rent liability, which is amortized as a reduction of rent expense over the non-cancelable term of its operating lease. Accrued Liabilities Accrued liabilities consisted of the following (in thousands):
Revenue Recognition The Company’s revenues generally consist of (i) contract and grant revenue – revenue generated under federal contracts and other awarded grants, and (ii) collaboration and licensing revenue – revenue related to non-refundable upfront fees, royalties and milestone payments earned under license agreements. Revenue is recognized in accordance with the criteria outlined in the Securities and Exchange Commission (SEC)’s Topic 13 and Accounting Standards Codification (ASC) 605-25 and by the Financial Accounting Standards Board. Following these accounting pronouncements, revenue is recognized when all four of the following criteria are met: (i) persuasive evidence of an arrangement exists; (ii) delivery of the products and/or services has occurred and risk of loss has passed; (iii) the selling price is fixed or determinable; and (iv) collectability is reasonably assured. For arrangements that involve the delivery of more than one element, each product, service and/or right to use assets is evaluated to determine whether it qualifies as a separate unit of accounting. This determination is based on whether the deliverable has “stand-alone value” to the customer. The consideration that is fixed or determinable is then allocated to each separate unit of accounting based on the relative selling prices of each deliverable. The consideration allocated to each unit of accounting is recognized as the related goods and services are delivered, limited to the consideration that is not contingent upon future deliverables. If the arrangement constitutes a single unit of accounting, the revenue recognition policy must be determined for the entire arrangement and the consideration received is recognized over the period of inception through the date the last deliverable within the single unit of accounting is expected to be delivered. Revisions to the estimated period of recognition are reflected in revenue prospectively. Non-refundable upfront fees are recorded as deferred revenue and recognized into revenue as license fees from collaborations on a straight-line basis over the estimated period of the Company’s substantive performance obligations. If the Company does not have substantive performance obligations, the Company recognizes non-refundable upfront fees into revenue through the date the deliverable is satisfied. Analyzing the arrangement to identify deliverables requires the use of judgment and each deliverable may be an obligation to deliver services, a right or license to use an asset, or another performance obligation. Milestone payments are recognized when earned, provided that (i) the milestone event is substantive; (ii) there is no ongoing performance obligation related to the achievement of the milestone earned; and (iii) it would result in additional payments. Milestone payments are considered substantive if all of the following conditions are met: the milestone payment is non-refundable; achievement of the milestone was not reasonably assured at the inception of the arrangement; substantive effort is involved to achieve the milestone; and the amount of the milestone appears reasonable in relation to the effort expended, the other milestones in the arrangement; and the related risk associated with the achievement of the milestone. Contingent based event payments the Company may receive under a license or collaboration agreement will be recognized when received. For the years ended December 31, 2017, 2016 and 2015, contract and grant revenue consisted only of revenue from the BARDA contract as there was no grant revenue. The Company recognizes contract and grant revenue as qualifying research activities are conducted based on invoices received from the Company’s vendors. Changes in fringe and indirect rates are recognized as a change in estimate in the period such rate changes are approved by BARDA. For the year ended December 31, 2015, collaboration and licensing revenue primarily consisted of the upfront license fee payment from ContraVir recognized when the Company completed its performance obligations. Research and Development Prepaids and Accruals As part of the process of preparing financial statements, the Company is required to estimate its expenses resulting from its obligation under contracts with vendors and consultants and clinical site agreements in connection with its research and development efforts. The financial terms of these contracts are subject to negotiations which vary contract to contract and may result in payment flows that do not match the periods over which materials or services are provided to the Company under such contracts. The Company’s objective is to reflect the appropriate research and development expenses in its financial statements by matching those expenses with the period in which services and efforts are expended. The Company accounts for these expenses according to the progress of its research and development efforts. The Company determines prepaid and accrual estimates through discussion with applicable personnel and outside service providers as to the progress or state of communication of clinical trials, or other services completed. The Company adjusts its rate of research and development expense recognition if actual results differ from its estimates. The Company makes estimates of its prepaid and accrued expenses as of each balance sheet date in its financial statements based on facts and circumstances known at that time. Although the Company does not expect its estimates to be materially different from amounts actually incurred, its understanding of status and timing of services performed relative to the actual status and timing of services performed may vary and may result in the Company reporting amounts that are too high or too low for any particular period. Through December 31, 2017, there had been no material adjustments to the Company’s prior period estimates of prepaid and accruals for research and development expenses. The Company’s research and development prepaids and accruals are dependent upon the timely and accurate reporting of contract research organizations and other third-party vendors. Research and Development Expenses Major components of research and development costs include cash compensation, stock based compensation, pre-clinical studies, clinical trial and related clinical manufacturing, drug development, materials and supplies, legal, regulatory compliance, and fees paid to consultants and other entities that conduct certain research and development activities on the Company’s behalf. Research and development costs, including upfront fees and milestones paid to contract research organizations, are expensed as goods as received or services rendered. Costs incurred in connection with clinical trial activities for which the underlying nature of the activities themselves do not directly relate to active research and development, such as costs incurred for market research and focus groups linked to clinical strategy as well as costs to build the Company’s brand, are not included in research and development costs but are reflected as general and administrative costs. Interest Income, Net Interest income, net primarily includes interest earned on short-term and long-term investments, interest incurred on loans payable, the amortization of deferred financing costs related to fees paid to attorneys and other non-lender entities in order to acquire debt, and the amortization of debt discount related to fees paid to the lender in order to acquire debt. Other-than-temporary Impairment of Investment Other-than-temporary impairment of investment includes write-downs in fair value of available-for-sale securities judged to be other-than-temporarily impaired. Income Taxes Deferred tax assets and liabilities are determined based on differences between the financial and tax reporting bases of assets and liabilities and are measured using enacted tax rates and laws that are expected to be in effect when the differences are expected to reverse. Valuation allowances are established when the Company determines that it is more likely than not that some portion of a deferred tax asset will not be realized. The Company has incurred operating losses from April 7, 2000 (inception) through December 31, 2017, and therefore has not recorded any current provision for income taxes. Additionally, the Company recognizes the tax benefit from an uncertain tax position only if it is more likely than not that the tax position will be sustained on examination by the taxing authorities based on the technical merits of the position. The tax benefit recognized in the financial statements for a particular tax position is based on the largest benefit that is more likely than not to be realized upon settlement. Accordingly, the Company establishes reserves for uncertain tax positions. Share-Based Compensation The Company measures and recognizes compensation expense for all share-based payment awards made to employees and directors, including employee stock options, restricted stock units and the employee stock purchase plan purchase rights, based on estimated fair values. The fair value of employee stock options and employee stock purchase plan purchase rights is estimated on the grant date using the Black-Scholes valuation model. The grant-date fair value for restricted stock units is based upon the market price of the Company's common stock on the date of the grant. The value of the portion of the award that is ultimately expected to vest is recorded as expense over the requisite service periods. For performance-based awards compensation cost is recognized when it is probable that the performance criteria will be met. The Company estimates forfeitures at the time of grant, and revises those estimates in subsequent periods if actual forfeitures differ from its estimates. The Company uses historical data to estimate forfeitures and record share-based compensation expense only for those awards that are expected to vest. To the extent that actual forfeitures differ from the Company’s estimates, the difference is recorded as a cumulative adjustment in the period the estimates were revised. For the years ended December 31, 2017, 2016 and 2015, the Company applied a forfeiture rate based on the Company’s historical forfeitures. 401(k) Plan The Company maintains a defined contribution employee retirement plan (“401(k) plan”). In March 2015, the Company began making matching contributions into the 401(k) plan on behalf of participants. For the years ended December 31, 2017, 2016 and 2015, the Company recognized expenses for matching contributions of $0.3 million, $0.4 million and $0.3 million, respectively. Basic and Dilutive Net Loss Per Share of Common Stock Basic net loss per share of common stock is computed by dividing net loss by the weighted-average number of shares of common stock outstanding during the period, excluding the dilutive effects of warrants to purchase common stock, non-vested restricted stock, stock options, and employee stock purchase plan purchase rights. Diluted net loss per share of common stock is computed by dividing net loss by the sum of the weighted-average number of shares of common stock outstanding during the period plus the potential dilutive effects of warrants to purchase common stock, non-vested restricted stock, stock options, and employee stock purchase plan purchase rights outstanding during the period calculated in accordance with the treasury stock method, but are excluded if their effect is anti-dilutive. Because the impact of these items is anti-dilutive during the periods of net loss, there was no difference between basic and diluted loss per share of common stock at December 31, 2017, 2016 and 2015. Segments The Company operates in only one segment. The chief operating decision-maker, who is the Company’s Chief Executive Officer, and management use cash flows as the primary measure to manage the business and do not segment the business for internal reporting or decision making. Impact of Recently Issued Accounting Standards In May 2014, the FASB issued Accounting Standards Update (ASU) No. 2014-09, “Revenue from Contracts with Customers (Topic 606).” The ASU establishes a principles-based approach for accounting for revenue arising from contracts with customers and supersedes existing revenue recognition guidance. The ASU provides that an entity should apply a five-step approach for recognizing revenue, including (1) identify the contract with a customer; (2) identify the performance obligations in the contract; (3) determine the transaction price; (4) allocate the transaction price to the performance obligations in the contract; and (5) recognize revenue when, or as, the entity satisfies a performance obligation. Also, the entity must provide various disclosures concerning the nature, amount and timing of revenue and cash flows arising from contracts with customers. The FASB has issued several updates to the standard which (1) defer the original effective date to annual periods and interim periods within those annual periods beginning after December 15, 2017, while allowing for early adoption as of January 1, 2017 (ASU 2015-14); (2) clarify the application of the principal versus agent guidance (ASU 2016-08); and (3) clarify the guidance on inconsequential and perfunctory promises and licensing (ASU 2016-10). The Company has evaluated its contract with BARDA and license agreement with ContraVir, and the adoption of the ASU will not have a material impact on its consolidated financial statements. The Company plans to use the full retrospective method of adoption effective January 1, 2018. The Company is implementing changes to its accounting policies, internal controls and disclosures to support the new standard; however, these changes are not anticipated to be significant. In January 2016, the FASB issued ASU No. 2016-01, “Financial Instruments-Overall (Subtopic 825-10)-Recognition and Measurement of Financial Assets and Financial Liabilities.” The new standard enhances reporting for financial instruments. The ASU is effective for financial statements issued for annual periods and interim periods within those annual periods beginning after December 15, 2017. Earlier adoption is permitted for interim and annual reporting periods as of the beginning of the fiscal year of adoption. The Company does not expect the adoption of ASU 2016-01 to have a material impact on its consolidated financial statements. In February 2016, the FASB issued ASU No. 2016-02, “Leases (Topic 842)”, which increases transparency and comparability among companies accounting for lease transactions. The most significant change of this update will require the recognition of lease assets and liabilities on the balance sheet for lessees for operating lease arrangements with lease terms greater than 12 months. This update will require a modified retrospective application which includes a number of optional practical expedients related to the identification and classification of leases commenced before the effective date. This ASU is effective for financial statements issued for annual periods and interim periods within those annual periods, beginning after December 18, 2018. The Company is currently analyzing the impact of the adoption of ASU No. 2016-02 on its consolidated financial statements. Impact of Recently Adopted Accounting Standards In March 2016, the FASB issued ASU No. 2016-09, "Improvements to Employee Share-Based Payment Accounting", which simplifies several aspects of accounting for share-based payment transactions, including the income tax consequences, classification of awards as either equity or liabilities, and classification on the statement of cash flows. The ASU was effective for financial statements issued for annual periods and interim periods within those annual periods, beginning after December 15, 2016, with early adoption permitted. ASU No. 2016-09 became effective for the Company beginning in the first quarter of 2017. The Company elected to continue estimating the number of awards expected to be forfeited and adjusting the estimate when it is no longer probable that the employee will fulfill the service condition. The Company's adoption of ASU No. 2016-09 did not have a material impact on its consolidated financial statements. |
Investments |
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Investments | Investments The following tables summarize the Company's short-term and long-term investments (in thousands):
The following tables summarize the Company's investments with unrealized losses, aggregated by investment type and the length of time that individual investments have been in a continuous unrealized loss position (in thousands, except number of securities):
The following table summarizes the scheduled maturity for the Company's investments at December 31, 2017 (in thousands):
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Property and Equipment |
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Property and Equipment | Property and Equipment Property and equipment, net of accumulated depreciation consisted of the following (in thousands):
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Loan Payable |
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Dec. 31, 2017 | |
Debt Disclosure [Abstract] | |
Loan Payable | Loan Payable On January 27, 2012, the Company entered into a Loan and Security Agreement (LSA) with Silicon Valley Bank (SVB) and MidCap Financial SBIC, LP (MidCap) allowing for borrowings up to $15.0 million, split between a first tranche of $3.0 million borrowed at the time of the agreement, and a second tranche of up to $12.0 million that was available to be drawn by December 31, 2012 upon meeting one of three stated financial and/or operational goals. The borrowings under the LSA were collateralized by a security interest in all of the Company's assets, excluding its intellectual property. The first tranche, which was paid in full as of June 30, 2015, had an interest-only period of twelve months followed by a principal and interest amortization period of 30 months with interest being charged at 8.25% per year. The second tranche, which was paid in full as of December 31, 2015, had an interest-only period of six months followed by a principal and interest amortization period of 32 months with interest being charged at 8.25%. There were certain fees in accordance with the LSA which were recorded as discounts or short-term liabilities depending on the nature of the fees and accreted through interest expense over the life of the loans. As of December 31, 2015, the LSA was paid in full and no amounts remain outstanding. |
Commitments and Contingencies |
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Commitments and Contingencies Disclosure [Abstract] | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Commitments and Contingencies | Commitments and Contingencies Leases The Company leases its facilities and certain office equipment under long-term non-cancelable operating leases that expire at various dates through 2021. The Company has the following minimum rental payments under non-cancelable operating lease obligations that existed at December 31, 2017 (in thousands):
Rent expense under non-cancelable operating leases and other month-to-month equipment rental agreements, including common area maintenance fees, totaled approximately $0.5 million, $0.7 million, and $0.6 million for the years ended December 31, 2017, 2016 and 2015, respectively. Sublease The Company subleases 3,537 square feet of its office space under a non-cancelable operating lease that expires February 2021. Total future minimum rentals under the non-cancelable operating sublease as of December 31, 2017 are presented below (in thousands):
Significance of Revenue Source The Company is the recipient of federal research contract funds from BARDA. Periodic audits are required under the grant and contract agreements and certain costs may be questioned as appropriate under the agreements. Management believes that such amounts in the current year, if any, are not significant. Accordingly, no provision for refundable amounts under the agreements has been made as of December 31, 2017 and 2016. Claims and Contingencies From time to time, the Company is subject to claims arising in the ordinary course of business. As of December 31, 2017, the Company has accrued a potential liability of $1 million to a former director related to an indemnification claim. |
Stockholders' Equity (Deficit) |
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Stockholders' Equity Note [Abstract] | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Stockholders' Equity (Deficit) | Stockholders’ Equity (Deficit) Common Stock The Company’s common stock consists of 200 million authorized shares at December 31, 2017 and 2016, and 47.5 million and 46.5 million shares issued and outstanding at December 31, 2017 and December 31, 2016, respectively. On June 16, 2015, the Company completed an underwritten public offering of 4,341,250 shares of common stock, including 566,250 shares sold pursuant to the full exercise of an option granted to the underwriters to purchase additional shares of common stock. All of the shares were offered by the Company at a price to the public of $39.75 per share. The net proceeds from this offering, after deducting underwriting discounts and commissions and other offering expenses payable by the Company, were approximately $161.9 million. Shares Reserved for Future Issuance The Company has reserved shares of common stock for future issuances as follows:
Stock Options In connection with the Company’s IPO, the Company adopted the 2013 Equity Incentive Plan (the 2013 Plan). The 2013 Plan provides for the grant of incentive stock options (ISOs), nonstatutory stock options (NSOs), stock appreciation rights, restricted stock awards, restricted stock unit (RSU) awards, performance-based stock awards, and other forms of equity compensation (collectively, stock awards), all of which may be granted to employees, including officers, non-employee directors and consultants of the Company and its affiliates. Additionally, the 2013 Plan provides for the grant of performance cash awards. ISOs may be granted only to employees. All other awards may be granted to employees, including officers, and to non-employee directors and consultants. Initially, the aggregate number of shares of common stock that may be issued pursuant to stock awards under the 2013 Plan was the sum of (i) 1,408,450 shares, plus (ii) 244,717 shares, which was the number of shares reserved for issuance under the Company’s 2012 Equity Incentive Plan (the 2012 Plan) at the time the 2013 Plan became effective, plus (iii) any shares subject to outstanding stock options or other stock awards that would have otherwise returned to the 2012 Plan (such as upon the expiration or termination of a stock award prior to vesting). Additionally, the number of shares of common stock reserved for issuance under the 2013 Plan will automatically increase on January 1 of each year, beginning on January 1, 2014 and continuing through and including January 1, 2023, by 2.5% of the total number of shares of capital stock outstanding on December 31 of the preceding calendar year, or a lesser number of shares determined by the Company’s board of directors. The maximum number of shares that may be issued upon the exercise of ISOs under the 2013 Plan is 2,816,901 shares. Following the effectiveness of the 2013 Plan in April 2013, no further grants were made under the 2012 Plan. At the Company's annual meeting held on June 20, 2014, shareholders approved a change to the annual automatic increase in the number of common shares to be reserved for issuance under the 2013 Plan by changing the percentage increase to 4.0%, or a lesser number of shares determined by the Company's board of directors. The Company estimates the fair value of its share-based awards to employees, directors and consultants using the Black-Scholes option-pricing model. The Black-Scholes model requires the input of highly complex and subjective assumptions, including (a) the expected stock price volatility, (b) the calculation of expected term of the award, (c) the risk-free interest rate and (d) expected dividends. Due to the Company’s limited operating history and historical and implied volatility data, the Company has based its estimates of expected volatility on a blend of Company specific historical data and a group of similar public traded companies. When selecting these public companies on which it has based its expected stock price volatility, the Company selected companies with comparable characteristics to it, including enterprise value, risk profiles, positions within the industry, and with historical share price information sufficient to meet the expected life of its stock options. For employee stock options, the Company uses historical exercise data to estimate the expected life. The risk-free interest rates for the periods within the expected life of the option are based on the U.S. Treasury instrument with a life that is similar to the expected life of the option grant. The Company has never paid, and does not expect to pay, dividends in the foreseeable future. The following table illustrates the assumptions for the Black-Scholes model used in determining the fair value of the stock options granted:
A summary of activity related to the Company’s stock options is as follows:
As of December 31, 2017, there was approximately $14.1 million of total unrecognized compensation cost related to non-vested share-based compensation arrangements granted under the 2013 Plan. That compensation cost is expected to be recognized over a weighted-average period of approximately 1.64 years. Other information regarding the Company’s stock options is as follows (in thousands, except per share data):
The following table summarizes, at December 31, 2017, by price range: (1) for stock option awards outstanding under the 2013 Plan, the number of stock option awards outstanding, their weighted-average remaining life and their weighted-average exercise price; and (2) for stock option awards exercisable under the 2013 Plan, the number of stock option awards exercisable and their weighted-average exercise price:
Employee Stock Purchase Plan In February 2013, the Company’s board of directors adopted the 2013 Employee Stock Purchase Plan (ESPP), which was subsequently ratified by stockholders and became effective in April 2013. The purpose of the ESPP is to retain the services of new employees and secure the services of new and existing employees while providing incentives for such individuals to exert maximum efforts toward the Company’s success and that of its affiliates. The ESPP initially authorized the issuance of 704,225 shares of common stock pursuant to purchase rights granted to the Company’s employees or to employees of any of its designated affiliates. The number of shares of common stock reserved for issuance will automatically increase on January 1 of each calendar year, from January 1, 2014 through January 1, 2023 by the least of (a) 1% of the total number of shares of common stock outstanding on December 31 of the preceding calendar year, (b) 422,535 shares, or (c) a number determined by the Company’s board of directors that is less than (a) and (b). The ESPP is intended to qualify as an “employee stock purchase plan” within the meaning of Section 423 of the Internal Revenue Code of 1986. The common stock reserved for future issuance under the ESPP was automatically increased by an additional 422,535 shares on January 1, 2016 and 2017, bringing the total number of shares of common stock that may be purchased under the ESPP to 1,803,726 and 2,226,261, respectively. The Company has reserved a total of 2,226,261 shares of common stock to be purchased under the ESPP, of which 1,861,472 and 1,612,759 shares remained available for purchase at December 31, 2017 and 2016, respectively. Eligible employees may authorize an amount up to 15% of their salary to purchase common stock at the lower of a 15% discount to the beginning price of their offering period or a 15% discount to the ending price of each six-month purchase interval. The ESPP also provides for an automatic reset feature to start participants on a new twenty-four month participation period in the event that the common stock market value on a purchase date is less than the common stock value on the first day of the twenty-four month offering period. The Company issued 173,822 and 108,109 shares of common stock pursuant to the ESPP for the year ended December 31, 2017 and 2016, respectively. Compensation expense for purchase rights under the ESPP related to the purchase discount and the “look-back” option were determined using a Black-Scholes option pricing model. The following table illustrates the assumptions for the Black-Scholes model used in determining the fair value of the ESPP purchase rights:
As of December 31, 2017, the Company had a liability of $0.2 million representing employees' contributions to the ESPP. Restricted Stock Units For the years ended December 31, 2017 and 2016, the Company issued RSUs to certain employees which vest based on service criteria. When vested, the RSU represents the right to be issued the number of shares of the Company's common stock that is equal to the number of RSUs granted. The grant date fair value for RSUs is based upon the market price of the Company's common stock on the date of the grant. The fair value is then amortized to compensation expense over the requisite service period or vesting term. For the years ended December 31, 2017 and 2016, the Company issued 744,450 and 203,400 shares of common stock pursuant to the vesting of RSUs, respectively. In January 2017, the Company also granted performance-based RSUs which, when vested, represent the right to be issued the number of shares of the Company's common stock that is equal to the number of RSUs granted. The grant date fair value for performance-based RSUs is based upon the market price of the Company's common stock on the date of the grant. For the portion of the performance-based RSUs of which the achievement of the performance condition is considered probable, the Company recognizes stock-based compensation expense on the related estimated fair value of such RSUs ratably for each vesting tranche from the service inception date to the end of the requisite service period. For the performance conditions that are not considered probable of achievement at the grant date or upon quarterly re-evaluation, prior to the event actually occurring, the Company begins recognizing the related stock-based compensation expense ratably when the event occurs or when the Company can determine that achievement of the performance condition is probable. In those cases, the Company recognizes the change in estimate at the time it determines the performance condition is probable of achievement (by recognizing stock-based compensation expense as cumulative catch-up adjustment as if the Company had estimated at the grant date that the performance condition would have been achieved) and recognize the remaining compensation cost through the end of the requisite service period. The Company issued no shares of common stock pursuant to the vesting of performance-based RSUs for the year ended December 31, 2017. A summary of activity related to the Company’s RSUs is as follows:
The total unrecognized compensation cost related to the non-vested RSUs as of December 31, 2017 was $3.5 million and will be recognized over a weighted average period of approximately 2.54 years. Warrants In February 2011, the Company issued warrants to purchase an aggregate of 5,501,215 shares of Series F redeemable convertible preferred stock at an exercise price of $2.045 per share. Upon the completion of the Company’s IPO in April 2013, these warrants were converted into warrants to purchase 1,549,628 shares of common stock at an exercise price of $7.26 per share. The warrants were exercisable at any time and expired on February 7, 2018. At December 31, 2017 and 2016, warrants for the purchase of 227,794 shares of common stock were issued, outstanding and exercisable. Stock-based Compensation For awards with only service conditions and graded-vesting features, the Company recognizes compensation expense on a straight-line basis over the requisite service period. Total stock-based compensation expense was as follows (in thousands):
Cash received from exercises under all share-based payment arrangements for 2017, 2016 and 2015 was $0.8 million, $0.6 million and $3.2 million, respectively. There was no actual tax benefit realized for the tax deductions from exercises of the share-based payment arrangements during 2017, 2016 or 2015. |
Income Taxes |
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Income Tax Disclosure [Abstract] | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Income Taxes | Income Taxes No income tax expense or benefit has been recorded for the years ended December 31, 2017, 2016 or 2015. This is due to the establishment of a valuation allowance against the deferred tax assets generated during those periods. At December 31, 2017, the Company has concluded that it is more likely than not that the Company may not realize the benefit of its deferred tax assets due to its history of losses. Accordingly, the net deferred tax assets have been fully reserved. A reconciliation of the difference between the benefit for income taxes and income taxes at the statutory U.S. federal income tax rate is as follows for the years ended December 31, 2017, 2016, and 2015 (in thousands, except percentages):
The components of deferred tax assets and liabilities at December 31, 2017 and 2016 were as follows (in thousands):
At December 31, 2017, the Company had net operating loss carryforwards for federal, state, and foreign tax purposes of approximately $408.1 million, $319.9 million and $0.4 million, respectively. At December 31, 2016, the Company had net operating loss carryforwards for federal and state tax purposes of approximately $356.1 million and $287.2 million, respectively. The federal losses begin to expire in 2020 and the state losses begin to expire in 2018. The foreign losses do not expire. In addition, the Company has tax credit carryforwards for federal tax purposes of approximately $16.6 million as of December 31, 2017, which begin to expire in 2022. The future utilization of net operating loss and tax credit carryforwards may be limited due to changes in ownership. Management has recorded a valuation allowance for all of the deferred tax assets due to the uncertainty of future taxable income. The Company incorporated a subsidiary in the United Kingdom in 2014. However, the subsidiary has had minimal activity since inception. The subsidiary recorded a net loss as of December 31, 2017 and a small amount of net income as of December 31, 2016 and as such, has no undistributed earnings. In general, if the Company experiences a greater than 50% aggregate change in ownership of certain significant stockholders over a three-year period (a Section 382 ownership change), utilization of its pre-change net operating loss carryforwards is subject to an annual limitation under Section 382 of the Internal Revenue Code (and similar state laws). The annual limitation generally is determined by multiplying the value of the Company’s stock at the time of such ownership change (subject to certain adjustments) by the applicable long-term tax-exempt rate. Such limitations may result in expiration of a portion of the net operating loss carryforwards before utilization and may be substantial. The ability of the Company to use its net operating loss carryforwards may be limited or lost if the Company experiences a Section 382 ownership change in connection with offerings or as a result of future changes in its stock ownership. Losses from a specific period may be subject to multiple limitations, and would generally be limited by the lowest of those limitations. The Company has determined that a Section 382 ownership change occurred in 2002, and as such, losses incurred prior to that date are subject to an annual limitation of at least $64,000. Additionally, the Company has determined that a Section 382 ownership change occurred in 2007, and as such, losses incurred prior to that date are subject to an annual limitation of at least $762,000. The Company evaluated Section 382 ownership changes subsequent to 2007 through September 30, 2015 and concluded that a Section 382 ownership change occurred in 2013 as a result of the initial public offering. As such, losses incurred prior to that date are subject to an annual limitation of at least $6.7 million. As of December 31, 2017, the Company has adopted ASU 2016-09 which is effective for public companies for annual periods beginning after December 15, 2016. The ASU requires all excess tax benefits and tax deficiencies to be recognized as income tax expense or benefit in the income statement in the year in which they occur. As such, the Company has grossed up its net operation loss deferred tax asset to include all excess tax benefits as of December 31, 2017. The Company has determined that there may be a future limitation on the Company’s ability to utilize its entire federal R&D credit carryover. Therefore, the Company recognized an uncertain tax benefit associated with the federal R&D credit carryover during the years ended December 31, 2017 and 2016, as follows (in thousands):
The change in the amount of the unrecognized tax benefits accrued for prior years is due to the change in the federal tax rate and is reflected as a component of such in the statutory rate reconciliation. The Company has determined that it had no other material uncertain tax benefits for the year ended December 31, 2017. As of January 1, 2018, due to the carry forward of unutilized net operating losses and research and development credits, the Company is subject to U.S. Federal and state income tax examinations for the tax years 2000 through 2017. The Company recognizes accrued interest related to unrecognized tax benefits in interest expense and penalties in operating expense. No amounts were accrued for the payment of interest and penalties at December 31, 2017. On December 22, 2017, the Tax Cuts and Jobs Act was enacted into law, which reduced the federal corporate income tax rate to 21% for tax years beginning after December 31, 2017. As a result of the new enacted tax rate, the Company adjusted its deferred tax assets as of December 31, 2017 by applying the new 21% rate, which resulted in a decrease to the deferred tax assets and a corresponding decrease to the valuation allowance of approximately $58 million. The Tax Legislation also implements a territorial tax system. Under the territorial tax system, in general, the Company's foreign earnings will no longer be subject to tax in the U.S. As part of transition to the territorial tax system the Tax Legislation includes a mandatory deemed repatriation of all undistributed foreign earnings that are subject to a U.S. income tax. The Company estimates that the deemed repatriation will not result in an additional U.S. income tax liability as it has no undistributed foreign earnings. The SEC staff issued Staff Accounting Bulletin No. 118, Income Tax Accounting Implications of the Tax Cuts and Jobs Act (SAB 118) which will allow the Company to record provisional amounts during a measurement period which is similar to the measurement period used when accounting for business combinations. Provisional amounts have been recorded related to deferred taxes for stock compensation and the deferred rate change. The Company will continue to assess the impact of the recently enacted tax law on its business and consolidated financial statements. |
Significant Agreements |
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Revenue Recognition [Abstract] | |
Significant Agreements | Significant Agreements The Regents of the University of California In May 2002, the Company entered into a license agreement with The Regents of the University of California (UC) under which the Company obtained an exclusive, worldwide license to UC’s patent rights in certain inventions (the UC Patent Rights) related to lipid-conjugated antiviral compounds and their use, including certain patents relating to brincidofovir. The license agreement was amended in September 2002 in order to expand the scope of the license and again in December 2010 in order to modify certain financial terms. The agreement was amended a third time in September 2011 to add additional patents related to certain metabolically stable lipid-conjugate compounds. A fourth amendment was executed in July 2012 to alter the rights and obligations of the parties in light of the Company’s current business plans. Under the license agreement, the Company is permitted to research, develop, manufacture and commercialize products utilizing the UC Patent Rights for all human and veterinary uses, and to sublicense such rights. UC retained the right, on behalf of itself and other non-profit institutions, to use the UC Patent Rights for educational and research purposes and to publish information about the UC Patent Rights. In consideration for the rights granted under the license agreement, the Company has issued UC an aggregate of 64,788 shares of common stock. As additional consideration, the Company is required to pay certain cash milestone payments in connection with the development and commercialization of compounds that are covered by the UC Patent Rights, plus certain annual fees to maintain such patents until the Company commercializes a product utilizing UC Patent Rights. In connection with the development and commercialization of brincidofovir and CMX157, the Company could be required to pay UC up to an aggregate of $3.4 million in milestone payments, assuming the achievement of all applicable milestone events under the license agreement. In addition, upon commercialization of any product utilizing the UC Patent Rights (which would include the commercialization of brincidofovir), the Company will be required to pay low single digit royalties on net sales of such product. The license agreement requires that we diligently develop, manufacture and commercialize compounds that are covered by the UC Patent Rights, and we have agreed to meet certain development and commercialization milestones. UC may, at its option, either terminate the license agreement or change the license granted from an exclusive license to a non-exclusive license if we fail to meet such development and commercialization milestones. We are currently in compliance with these milestone requirements. In the event the Company sublicenses a UC Patent Right (including UC Patent Rights relating to brincidofovir or CMX157) the Company is obligated to pay to UC a fee, which amount will vary depending upon the amount of any payments the Company receives and the clinical development stage of the compound being sublicensed, but which could be up to approximately 50% of the sublicense fee in certain circumstances. With respect to brincidofovir, the fee payable to UC will not exceed 5% of the sublicense fee. In addition, the Company will also be required to pay to UC a low single digit sublicense royalty on net sales of products that use the sublicensed UC Patent Rights, but in no event will the Company be required to pay more than 50% of the royalties it receives in connection with the relevant sublicense. Any such royalty payment will be reduced by other payments the Company is required to make to third parties until a minimum royalty has been reached. Biomedical Advanced Research and Development Authority (BARDA) In February 2011, the Company entered into a contract with BARDA for the advanced development of brincidofovir as a medical countermeasure in the event of a smallpox release. Under the contract, BARDA will reimburse the Company, plus pay a fixed fee, for the research and development of brincidofovir as a broad-spectrum therapeutic antiviral for the treatment of smallpox infections. The contract consists of an initial performance period, referred to as the base performance segment, plus up to four extension periods, referred to as option segments, each of which may be exercised at BARDA’s sole discretion. The Company must complete the agreed upon milestones and deliverables in each discrete work segment before the next option segment is eligible to be exercised. Under the contract as currently in effect, the Company may receive up to $75.8 million in expense reimbursement and $5.3 million in fees. The Company is currently performing under the second and third option segments of the contract during which the Company may receive up to a total of $21.6 million and $11.6 million in expense reimbursement and fees, respectively. The second and third option segments are scheduled to end on September 30, 2018. As of December 31, 2017, the Company has recognized revenue in aggregate of $56.1 million with respect to the base performance segment and the first three extension periods. ContraVir Pharmaceuticals On December 17, 2014, the Company entered into a license agreement with ContraVir Pharmaceuticals (NASDAQ: CTRV) for the development and commercialization of CMX157 for certain antiviral indications. Under the terms of the agreement, ContraVir has sole responsibility with respect to the control of the development and commercialization of CMX157. In exchange for the license to CMX157 rights, the Company received an upfront payment consisting of 120,000 shares of ContraVir Series B Convertible Preferred Stock with a stated value of $1.2 million. In addition, the Company is eligible to receive up to approximately $20 million in clinical, regulatory and initial commercial milestones in the United States and Europe, as well as royalties and additional milestones based on commercial sales in those territories. Either party may terminate the license agreement upon the occurrence of a material breach by the other party (subject to standard cure periods), or upon certain events involving the bankruptcy or insolvency of the other party. ContraVir may also terminate the license agreement without cause on a country-by-country basis upon sixty days’ prior written notice. The upfront payment of 120,000 shares of ContraVir Series B Convertible Preferred Stock was valued at $1.5 million at the time of the agreement. The Company recorded this amount as a long-term investment and deferred revenue, which is included in accrued liabilities in the Consolidated Balance Sheets. Upon completion of the transfer of the IND and technical know-how related to CMX157 in April 2015, the Company recognized the $1.5 million upfront payment as revenue. In September 2016, the Company converted its shares of ContraVir Series B convertible preferred stock into 1,071,429 shares of ContraVir common stock. As of December 31, 2017 and 2016, the fair value of the investment was recorded as a short-term investment of $0.4 million and $1.3 million, respectively. University of Michigan In 2006, the Company entered into a license agreement with The Regents of the University of Michigan (UM) under which the Company obtained an exclusive, worldwide license to UM’s patent rights in certain inventions (UM Patent Rights) related to certain compounds originally synthesized at UM. Under the license agreement, the Company is permitted to research, develop, manufacture and commercialize products utilizing the UM Patent Rights, and to sublicense such rights subject to certain sublicensing fees and royalty payments. In consideration for the rights granted to the Company, under the license agreement as amended in December 2016, the Company paid UM $50,000 in fees in 2016 and in January 2017 issued UM an aggregate of 33,058 shares of its common stock. In connection with the Company's commercialization or sublicensing of certain products covered by the license agreement, including CMX521, the Company could be required to pay royalties on net sales of such products ranging from 0.25% to 2%. Beginning in 2024, the Company is also subject to certain minimum annual royalty payments. The UM license agreement requires that the Company uses commercially reasonable efforts to develop and make commercially available licensed products as soon as practicable. Specifically, the Company has agreed to make the first commercial sale of a licensed product by June of 2026. UM may terminate the license agreement if the Company materially breaches the license agreement. The Company is currently in compliance with its milestone requirements. |
Selected Quarterly Financial Data (Unaudited) |
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Selected Quarterly Financial Information [Abstract] | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Selected Quarterly Financial Data (Unaudited) | Selected Quarterly Financial Data (Unaudited) The following financial information reflects all normal recurring adjustments, which are, in the opinion of management, necessary for a fair statement of the results of the interim periods. Summarized quarterly data for 2017 and 2016 are as follows (in thousands, except share and per share data):
Net loss per share is computed independently for each of the quarters presented. Therefore, the sum of the quarterly per share calculations will not necessarily equal the annual per share calculation. Diluted weighted-average shares outstanding are identical to basic weighted-average shares outstanding and diluted net loss per share is identical to basic net loss per share for all quarters of 2017 and 2016. |
Subsequent Events |
12 Months Ended |
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Dec. 31, 2017 | |
Subsequent Events [Abstract] | |
Subsequent Events | Subsequent Events The Company has evaluated subsequent events through the issuance date of these financial statements to ensure that this filing includes appropriate disclosure of events both recognized in the financial statements as of December 31, 2017, and events which occurred subsequently but were not recognized in the financial statements. |
The Business and Summary of Significant Accounting Policies (Policies) |
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Accounting Policies [Abstract] | |||||||||||||
Basis of Presentation | Basis of Presentation The consolidated financial statements include the accounts of the Company, and its wholly owned subsidiaries. The accompanying consolidated financial statements have been prepared in accordance with accounting principles generally accepted in the United States of America (GAAP). The preparation of the Company’s consolidated financial statements requires estimates and assumptions that affect the reported amounts of assets, liabilities, revenues and expenses, and the disclosure of contingent assets and liabilities in the consolidated financial statements and accompanying notes. Although these estimates are based on knowledge of current events and actions the Company may undertake in the future, actual results may ultimately differ from these estimates and assumptions. |
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Reclassifications | Reclassifications Certain prior period amounts in the accompanying consolidated financial statements have been reclassified to conform to the current year presentation. These reclassifications had no effect on previously reported net income or stockholders' equity (deficit). |
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Cash and Cash Equivalents | Cash and Cash Equivalents The Company considers any highly liquid instrument with an original maturity of three months or less at acquisition to be a cash equivalent. Cash equivalents consist of money market funds and commercial paper. |
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Investments and Other-than-temporary Impairment of Investment | Investments Investments consist primarily of brokered certificates of deposit, U.S. Treasury securities and stock of a U.S. corporation. The Company invests in high-credit quality investments in accordance with its investment policy which minimizes the probability of loss. Available-for-sale securities are carried at fair value as determined by quoted market prices, with the unrealized gains and losses, net of tax, reported as a separate component of stockholders equity. Realized gains and losses are determined using the specific identification method and transactions are recorded on a settlement date basis in interest income or expense, net. Investments with original maturities beyond three months at the date of purchase and which mature on, or less than twelve months from, the balance sheet date are classified as short-term. Investments with a maturity beyond twelve months from the balance sheet date are classified as long-term. The Company periodically reviews available-for-sale securities for other-than-temporary declines in fair value below the cost basis and whenever events or changes in circumstances indicate that the carrying amount of an asset may not be recoverable. The Company evaluates, among other things, the duration and extent to which the fair value of a security is less than its cost; the financial condition of the issuer and any changes thereto; and the Company’s intent to sell, or whether it will more likely than not be required to sell, the security before recovery of its amortized cost basis. The Company does not intend to sell, and is not likely to be required to sell, the available-for-sale securities in an unrealized loss position before recovery of the amortized cost bases of the securities, which may be maturity. Any such declines in value judged to be other-than-temporary on available-for-sale securities are reported in other-than-temporary impairment of investment. For the year ended December 31, 2017, the Company determined the decline in value for its investment in ContraVir Pharmaceuticals common stock to be other-than temporary. As such, during the fourth quarter of 2017, the Company reclassified a loss of $1.2 million from accumulated other comprehensive loss, net in the Consolidated Balance Sheets to other-than-temporary impairment of investment in the Consolidated Statements of Operations and Comprehensive Loss. There were no such declines in value for the years ended December 31, 2016 and 2015. The Company recognizes interest income on an accrual basis in interest income, net in the Consolidated Statements of Operations and Comprehensive Loss. Other-than-temporary Impairment of Investment Other-than-temporary impairment of investment includes write-downs in fair value of available-for-sale securities judged to be other-than-temporarily impaired. |
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Concentration of Credit Risk | Concentration of Credit Risk Financial instruments that potentially subject the Company to concentrations of credit risk consist of cash, cash equivalents, short-term investments, long-term investments and accounts receivable. The Company is exposed to credit risk, subject to federal deposit insurance, in the event of default by the financial institutions holding its cash and cash equivalents to the extent of amounts recorded on the balance sheets. Accounts receivable represent amounts due from an agency of the federal government. |
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Accounts Receivable | Accounts Receivable Accounts receivable at December 31, 2017 and December 31, 2016 consisted of amounts billed under the Company’s contract with the Biomedical Advanced Research and Development Authority (BARDA). Receivables under the BARDA contract are recorded as qualifying research activities are conducted and invoices from the Company’s vendors are received. The Company carries its accounts receivable at cost less an allowance for doubtful accounts. On a periodic basis, the Company evaluates its accounts receivable and establishes an allowance based on its history of collections and write-offs and the current status of all receivables. The Company does not accrue interest on trade receivables. If accounts become uncollectible, they will be written off through a charge to the allowance for doubtful accounts. The Company has not recorded a charge to allowance for doubtful accounts as management believes all receivables are fully collectible. |
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Fair Value of Financial Instruments | Fair Value of Financial Instruments The carrying amounts of certain financial instruments, including accounts receivable, accounts payable and accrued expenses approximate their fair values due to the short-term nature of such instruments. For assets and liabilities recorded at fair value, it is the Company’s policy to maximize the use of observable inputs and minimize the use of unobservable inputs when developing fair value measurements, in accordance with the fair value hierarchy. Fair value measurements for assets and liabilities where there exists limited or no observable market data are based primarily upon estimates and are often calculated based on the economic and competitive environment, the characteristics of the asset or liability and other factors. Therefore, fair value measurements cannot be determined with precision and may not be realized in an actual sale or immediate settlement of the asset or liability. Additionally, there may be inherent weaknesses in any calculation technique and changes in the underlying assumptions used, including discount rates and estimates of future cash flows, could significantly affect the calculated current or future fair values. The Company utilizes fair value measurements to record fair value adjustments to certain assets and liabilities and to determine fair value disclosures. The Company groups assets and liabilities at fair value in three levels, based on the markets in which the assets and liabilities are traded and the reliability of the assumptions used to determine fair value. An adjustment to the pricing method used within either Level 1 or Level 2 inputs could generate a fair value measurement that effectively falls in a lower level in the hierarchy. These levels are:
The determination of where an asset or liability falls in the hierarchy requires significant judgment. The Company evaluates hierarchy disclosures and, based on various factors, it is possible that an asset or liability may be classified differently from period to period. However, the Company expects that changes in classification between levels will be rare. There were no transfers between Level 1 and Level 2 or transfers to or from Level 3 during the year ended December 31, 2017. When the 18 month restriction on selling the Company's investment in ContraVir Pharmaceuticals ended on June 17, 2016, the investment was transferred from Level 3 to Level 2 as the fair value was based on quoted prices for similar assets and there were no significant unobservable inputs. The Company's investment in ContraVir Pharmaceuticals transferred from Level 2 to Level 1 when the Company converted its investment in Series B Preferred shares into common stock in September 2016. At December 31, 2017 and 2016, the Company had cash equivalents, consisting of money market funds, and short-term and long-term investments consisting of U.S. Treasury securities, whose value is based on using quoted market prices. Accordingly, these securities are classified as Level 1. At December 31, 2017, the Company had cash equivalents, consisting of commercial paper, and at December 31, 2016, the Company had cash equivalents consisting of commercial paper, and short-term investments comprised of brokered certificates of deposits, for which quoted prices are not available that are valued using independent pricing models or other model-based valuation techniques such as the present value of future cash flows, adjusted for the security’s credit rating, prepayment assumptions and other factors such as credit loss assumptions. Accordingly, these securities are classified as Level 2. At December 31, 2015, the Company's preferred stock investment in ContraVir Pharmaceuticals was categorized as Level 3 as there were significant unobservable inputs. The valuation of the investment at December 31, 2015 was calculated on an as if converted to common share basis with a discount for lack of marketability applied due to the 18 month restriction from the date of the investment on selling the converted common shares, which ended on June 17, 2016. An option pricing model was used to determine the discount for lack of marketability of 10% at December 31, 2015. The key unobservable inputs used in the option pricing model at December 31, 2015 were (i) exercise price - $1.54, (ii) dividend yield - 0%, (iii) expected holding period - 0.46 years, (iv) risk-free rate - 0.44%, and (v) volatility - 75%. On September 30, 2016, the Company converted its preferred stock investment in ContraVir into 1,071,429 shares of ContraVir common stock, which was categorized as a Level 1 asset and valued based on ContraVir's common stock value. The Company evaluates, among other things, the duration and extent to which the fair value of a security is less than its cost; the financial condition of the issuer and any changes thereto; and the Company’s intent to sell, or whether it will more likely than not be required to sell, the security before recovery of its market value. For the years ended December 31, 2016 and 2015, the Company did not intend to sell, and was not more likely than not to be required to sell, its investment in ContraVir before recovery of its market value, therefore the changes in the fair value of ContraVir common shares was recorded to unrealized (loss) gain on investments, net in the Consolidated Statements of Operations and Comprehensive Loss. There was no material re-measurement to fair value of financial assets and liabilities that are not measured at fair value on a recurring basis. |
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Property and Equipment | Property and Equipment Property and equipment are stated at cost, less accumulated depreciation. Depreciation is determined on a straight-line basis over the estimated useful lives of the assets, which generally range from three to five years. Leasehold improvements are amortized over the shorter of the useful life of the asset or the term of the related lease. Maintenance and repairs are charged against expense as incurred. |
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Impairment of Long-Lived Assets | Impairment of Long-Lived Assets The Company evaluates long-lived assets for impairment whenever events or changes in circumstances indicate that the carrying value of an asset may not be recoverable. If the estimated future cash flows (undiscounted and without interest charges) from the use of an asset are less than the carrying value, a write-down would be recorded to reduce the related asset to its estimated fair value. |
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Deferred Lease Obligation | Deferred Lease Obligations The Company recognizes rent expense on a straight-line basis over the non-cancelable term of its operating lease and records the difference between cash rent payments and the recognition of rent expense as a deferred rent liability. The Company also records landlord-funded lease incentives, such as reimbursable leasehold improvements, as a deferred rent liability, which is amortized as a reduction of rent expense over the non-cancelable term of its operating lease. |
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Revenue Recognition | Revenue Recognition The Company’s revenues generally consist of (i) contract and grant revenue – revenue generated under federal contracts and other awarded grants, and (ii) collaboration and licensing revenue – revenue related to non-refundable upfront fees, royalties and milestone payments earned under license agreements. Revenue is recognized in accordance with the criteria outlined in the Securities and Exchange Commission (SEC)’s Topic 13 and Accounting Standards Codification (ASC) 605-25 and by the Financial Accounting Standards Board. Following these accounting pronouncements, revenue is recognized when all four of the following criteria are met: (i) persuasive evidence of an arrangement exists; (ii) delivery of the products and/or services has occurred and risk of loss has passed; (iii) the selling price is fixed or determinable; and (iv) collectability is reasonably assured. For arrangements that involve the delivery of more than one element, each product, service and/or right to use assets is evaluated to determine whether it qualifies as a separate unit of accounting. This determination is based on whether the deliverable has “stand-alone value” to the customer. The consideration that is fixed or determinable is then allocated to each separate unit of accounting based on the relative selling prices of each deliverable. The consideration allocated to each unit of accounting is recognized as the related goods and services are delivered, limited to the consideration that is not contingent upon future deliverables. If the arrangement constitutes a single unit of accounting, the revenue recognition policy must be determined for the entire arrangement and the consideration received is recognized over the period of inception through the date the last deliverable within the single unit of accounting is expected to be delivered. Revisions to the estimated period of recognition are reflected in revenue prospectively. Non-refundable upfront fees are recorded as deferred revenue and recognized into revenue as license fees from collaborations on a straight-line basis over the estimated period of the Company’s substantive performance obligations. If the Company does not have substantive performance obligations, the Company recognizes non-refundable upfront fees into revenue through the date the deliverable is satisfied. Analyzing the arrangement to identify deliverables requires the use of judgment and each deliverable may be an obligation to deliver services, a right or license to use an asset, or another performance obligation. Milestone payments are recognized when earned, provided that (i) the milestone event is substantive; (ii) there is no ongoing performance obligation related to the achievement of the milestone earned; and (iii) it would result in additional payments. Milestone payments are considered substantive if all of the following conditions are met: the milestone payment is non-refundable; achievement of the milestone was not reasonably assured at the inception of the arrangement; substantive effort is involved to achieve the milestone; and the amount of the milestone appears reasonable in relation to the effort expended, the other milestones in the arrangement; and the related risk associated with the achievement of the milestone. Contingent based event payments the Company may receive under a license or collaboration agreement will be recognized when received. For the years ended December 31, 2017, 2016 and 2015, contract and grant revenue consisted only of revenue from the BARDA contract as there was no grant revenue. The Company recognizes contract and grant revenue as qualifying research activities are conducted based on invoices received from the Company’s vendors. Changes in fringe and indirect rates are recognized as a change in estimate in the period such rate changes are approved by BARDA. For the year ended December 31, 2015, collaboration and licensing revenue primarily consisted of the upfront license fee payment from ContraVir recognized when the Company completed its performance obligations. |
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Research and Development Prepaids and Accruals | Research and Development Prepaids and Accruals As part of the process of preparing financial statements, the Company is required to estimate its expenses resulting from its obligation under contracts with vendors and consultants and clinical site agreements in connection with its research and development efforts. The financial terms of these contracts are subject to negotiations which vary contract to contract and may result in payment flows that do not match the periods over which materials or services are provided to the Company under such contracts. The Company’s objective is to reflect the appropriate research and development expenses in its financial statements by matching those expenses with the period in which services and efforts are expended. The Company accounts for these expenses according to the progress of its research and development efforts. The Company determines prepaid and accrual estimates through discussion with applicable personnel and outside service providers as to the progress or state of communication of clinical trials, or other services completed. The Company adjusts its rate of research and development expense recognition if actual results differ from its estimates. The Company makes estimates of its prepaid and accrued expenses as of each balance sheet date in its financial statements based on facts and circumstances known at that time. Although the Company does not expect its estimates to be materially different from amounts actually incurred, its understanding of status and timing of services performed relative to the actual status and timing of services performed may vary and may result in the Company reporting amounts that are too high or too low for any particular period. Through December 31, 2017, there had been no material adjustments to the Company’s prior period estimates of prepaid and accruals for research and development expenses. The Company’s research and development prepaids and accruals are dependent upon the timely and accurate reporting of contract research organizations and other third-party vendors. |
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Research and Development Expenses | Research and Development Expenses Major components of research and development costs include cash compensation, stock based compensation, pre-clinical studies, clinical trial and related clinical manufacturing, drug development, materials and supplies, legal, regulatory compliance, and fees paid to consultants and other entities that conduct certain research and development activities on the Company’s behalf. Research and development costs, including upfront fees and milestones paid to contract research organizations, are expensed as goods as received or services rendered. Costs incurred in connection with clinical trial activities for which the underlying nature of the activities themselves do not directly relate to active research and development, such as costs incurred for market research and focus groups linked to clinical strategy as well as costs to build the Company’s brand, are not included in research and development costs but are reflected as general and administrative costs. |
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Interest Income, Net | Interest Income, Net Interest income, net primarily includes interest earned on short-term and long-term investments, interest incurred on loans payable, the amortization of deferred financing costs related to fees paid to attorneys and other non-lender entities in order to acquire debt, and the amortization of debt discount related to fees paid to the lender in order to acquire debt. |
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Income Taxes | Income Taxes Deferred tax assets and liabilities are determined based on differences between the financial and tax reporting bases of assets and liabilities and are measured using enacted tax rates and laws that are expected to be in effect when the differences are expected to reverse. Valuation allowances are established when the Company determines that it is more likely than not that some portion of a deferred tax asset will not be realized. The Company has incurred operating losses from April 7, 2000 (inception) through December 31, 2017, and therefore has not recorded any current provision for income taxes. Additionally, the Company recognizes the tax benefit from an uncertain tax position only if it is more likely than not that the tax position will be sustained on examination by the taxing authorities based on the technical merits of the position. The tax benefit recognized in the financial statements for a particular tax position is based on the largest benefit that is more likely than not to be realized upon settlement. Accordingly, the Company establishes reserves for uncertain tax positions. |
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Share-Based Compensation | Share-Based Compensation The Company measures and recognizes compensation expense for all share-based payment awards made to employees and directors, including employee stock options, restricted stock units and the employee stock purchase plan purchase rights, based on estimated fair values. The fair value of employee stock options and employee stock purchase plan purchase rights is estimated on the grant date using the Black-Scholes valuation model. The grant-date fair value for restricted stock units is based upon the market price of the Company's common stock on the date of the grant. The value of the portion of the award that is ultimately expected to vest is recorded as expense over the requisite service periods. For performance-based awards compensation cost is recognized when it is probable that the performance criteria will be met. The Company estimates forfeitures at the time of grant, and revises those estimates in subsequent periods if actual forfeitures differ from its estimates. The Company uses historical data to estimate forfeitures and record share-based compensation expense only for those awards that are expected to vest. To the extent that actual forfeitures differ from the Company’s estimates, the difference is recorded as a cumulative adjustment in the period the estimates were revised. For the years ended December 31, 2017, 2016 and 2015, the Company applied a forfeiture rate based on the Company’s historical forfeitures. |
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401(k) Plan | 401(k) Plan The Company maintains a defined contribution employee retirement plan (“401(k) plan”). In March 2015, the Company began making matching contributions into the 401(k) plan on behalf of participants. |
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Basic and Dilutive Net Loss Per Share of Common Stock | Basic and Dilutive Net Loss Per Share of Common Stock Basic net loss per share of common stock is computed by dividing net loss by the weighted-average number of shares of common stock outstanding during the period, excluding the dilutive effects of warrants to purchase common stock, non-vested restricted stock, stock options, and employee stock purchase plan purchase rights. Diluted net loss per share of common stock is computed by dividing net loss by the sum of the weighted-average number of shares of common stock outstanding during the period plus the potential dilutive effects of warrants to purchase common stock, non-vested restricted stock, stock options, and employee stock purchase plan purchase rights outstanding during the period calculated in accordance with the treasury stock method, but are excluded if their effect is anti-dilutive. Because the impact of these items is anti-dilutive during the periods of net loss, there was no difference between basic and diluted loss per share of common stock at December 31, 2017, 2016 and 2015. |
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Segments | Segments The Company operates in only one segment. The chief operating decision-maker, who is the Company’s Chief Executive Officer, and management use cash flows as the primary measure to manage the business and do not segment the business for internal reporting or decision making. |
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Impact of Recently Issued Accounting Standards and Impact of Recently Adopted Accounting Standards | Impact of Recently Issued Accounting Standards In May 2014, the FASB issued Accounting Standards Update (ASU) No. 2014-09, “Revenue from Contracts with Customers (Topic 606).” The ASU establishes a principles-based approach for accounting for revenue arising from contracts with customers and supersedes existing revenue recognition guidance. The ASU provides that an entity should apply a five-step approach for recognizing revenue, including (1) identify the contract with a customer; (2) identify the performance obligations in the contract; (3) determine the transaction price; (4) allocate the transaction price to the performance obligations in the contract; and (5) recognize revenue when, or as, the entity satisfies a performance obligation. Also, the entity must provide various disclosures concerning the nature, amount and timing of revenue and cash flows arising from contracts with customers. The FASB has issued several updates to the standard which (1) defer the original effective date to annual periods and interim periods within those annual periods beginning after December 15, 2017, while allowing for early adoption as of January 1, 2017 (ASU 2015-14); (2) clarify the application of the principal versus agent guidance (ASU 2016-08); and (3) clarify the guidance on inconsequential and perfunctory promises and licensing (ASU 2016-10). The Company has evaluated its contract with BARDA and license agreement with ContraVir, and the adoption of the ASU will not have a material impact on its consolidated financial statements. The Company plans to use the full retrospective method of adoption effective January 1, 2018. The Company is implementing changes to its accounting policies, internal controls and disclosures to support the new standard; however, these changes are not anticipated to be significant. In January 2016, the FASB issued ASU No. 2016-01, “Financial Instruments-Overall (Subtopic 825-10)-Recognition and Measurement of Financial Assets and Financial Liabilities.” The new standard enhances reporting for financial instruments. The ASU is effective for financial statements issued for annual periods and interim periods within those annual periods beginning after December 15, 2017. Earlier adoption is permitted for interim and annual reporting periods as of the beginning of the fiscal year of adoption. The Company does not expect the adoption of ASU 2016-01 to have a material impact on its consolidated financial statements. In February 2016, the FASB issued ASU No. 2016-02, “Leases (Topic 842)”, which increases transparency and comparability among companies accounting for lease transactions. The most significant change of this update will require the recognition of lease assets and liabilities on the balance sheet for lessees for operating lease arrangements with lease terms greater than 12 months. This update will require a modified retrospective application which includes a number of optional practical expedients related to the identification and classification of leases commenced before the effective date. This ASU is effective for financial statements issued for annual periods and interim periods within those annual periods, beginning after December 18, 2018. The Company is currently analyzing the impact of the adoption of ASU No. 2016-02 on its consolidated financial statements. Impact of Recently Adopted Accounting Standards In March 2016, the FASB issued ASU No. 2016-09, "Improvements to Employee Share-Based Payment Accounting", which simplifies several aspects of accounting for share-based payment transactions, including the income tax consequences, classification of awards as either equity or liabilities, and classification on the statement of cash flows. The ASU was effective for financial statements issued for annual periods and interim periods within those annual periods, beginning after December 15, 2016, with early adoption permitted. ASU No. 2016-09 became effective for the Company beginning in the first quarter of 2017. The Company elected to continue estimating the number of awards expected to be forfeited and adjusting the estimate when it is no longer probable that the employee will fulfill the service condition. The Company's adoption of ASU No. 2016-09 did not have a material impact on its consolidated financial statements. |
The Business and Summary of Significant Accounting Policies (Tables) |
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Accounting Policies [Abstract] | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Assets and Liabilities Measured at Fair Value on a Recurring Basis | Below is a table that presents information about certain assets measured at fair value on a recurring basis (in thousands):
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Reconciliation of Assets and Liabilities Measured at Fair Value on a Recurring Basis | Below is a table that presents a reconciliation of the beginning and ending balances of assets and liabilities measured at fair value on a recurring basis using significant unobservable inputs (Level 3) (in thousands):
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Schedule of Prepaid and Other Current Assets | Prepaid expenses and other current assets consisted of the following (in thousands):
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Schedule of Accrued Liabilities | Accrued liabilities consisted of the following (in thousands):
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Investments (Tables) |
12 Months Ended | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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Dec. 31, 2017 | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Investments [Abstract] | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Summary of Short-term and Long-term Investments | The following tables summarize the Company's short-term and long-term investments (in thousands):
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Summary of Investments with Unrealized Losses, Aggregated by Investment Type and the Length of Time | The following tables summarize the Company's investments with unrealized losses, aggregated by investment type and the length of time that individual investments have been in a continuous unrealized loss position (in thousands, except number of securities):
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Summary of the scheduled maturity of Company investments | The following table summarizes the scheduled maturity for the Company's investments at December 31, 2017 (in thousands):
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Property and Equipment (Tables) |
12 Months Ended | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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Dec. 31, 2017 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Property, Plant and Equipment [Abstract] | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Summary of Property and Equipment, net | Property and equipment, net of accumulated depreciation consisted of the following (in thousands):
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Commitments and Contingencies (Tables) |
12 Months Ended | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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Dec. 31, 2017 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Commitments and Contingencies Disclosure [Abstract] | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Schedule of Future Minimum Rental Payments for Operating Leases | Total future minimum rentals under the non-cancelable operating sublease as of December 31, 2017 are presented below (in thousands):
The Company has the following minimum rental payments under non-cancelable operating lease obligations that existed at December 31, 2017 (in thousands):
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Stockholders' Equity (Deficit) (Tables) |
12 Months Ended | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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Dec. 31, 2017 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Stockholders' Equity Note [Abstract] | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Schedule of Shares Reserved for Future Issuance | The Company has reserved shares of common stock for future issuances as follows:
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Schedule of Fair Value Assumptions, Stock Options | The following table illustrates the assumptions for the Black-Scholes model used in determining the fair value of the stock options granted:
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Summary of Activity Related to Stock Options | A summary of activity related to the Company’s stock options is as follows:
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Schedule of Other Information Regarding Stock Options | Other information regarding the Company’s stock options is as follows (in thousands, except per share data):
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Schedule of Share-based Compensation, Shares Authorized | The following table summarizes, at December 31, 2017, by price range: (1) for stock option awards outstanding under the 2013 Plan, the number of stock option awards outstanding, their weighted-average remaining life and their weighted-average exercise price; and (2) for stock option awards exercisable under the 2013 Plan, the number of stock option awards exercisable and their weighted-average exercise price:
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Schedule of Fair Value Assumptions, Employee Stock Purchase Plan | The following table illustrates the assumptions for the Black-Scholes model used in determining the fair value of the ESPP purchase rights:
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Summary of Activity Related to Restricted Stock Units | A summary of activity related to the Company’s RSUs is as follows:
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Schedule of Employee Service Share-based Compensation, Allocation of Recognized Period Costs | For awards with only service conditions and graded-vesting features, the Company recognizes compensation expense on a straight-line basis over the requisite service period. Total stock-based compensation expense was as follows (in thousands):
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Income Taxes (Tables) |
12 Months Ended | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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Dec. 31, 2017 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Income Tax Disclosure [Abstract] | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Reconciliation of the Difference between the Benefit for Income Taxes and Income Taxes at the Statutory U.S. Federal Income Tax Rate | A reconciliation of the difference between the benefit for income taxes and income taxes at the statutory U.S. federal income tax rate is as follows for the years ended December 31, 2017, 2016, and 2015 (in thousands, except percentages):
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Components of Deferred Tax Assets and Liabilities | The components of deferred tax assets and liabilities at December 31, 2017 and 2016 were as follows (in thousands):
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Summary of Uncertain Tax Benefit | Therefore, the Company recognized an uncertain tax benefit associated with the federal R&D credit carryover during the years ended December 31, 2017 and 2016, as follows (in thousands):
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Selected Quarterly Financial Data (Unaudited) (Tables) |
12 Months Ended | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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Dec. 31, 2017 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Selected Quarterly Financial Information [Abstract] | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Schedule of Quarterly Financial Information | The following financial information reflects all normal recurring adjustments, which are, in the opinion of management, necessary for a fair statement of the results of the interim periods. Summarized quarterly data for 2017 and 2016 are as follows (in thousands, except share and per share data):
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The Business and Summary of Significant Accounting Policies (Reconciliation of Liabilities Measured at Fair Value on a Recurring Basis) (Details) - Preferred stock of U.S. corporation - Significant Unobservable Inputs (Level 3) $ in Thousands |
12 Months Ended |
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Dec. 31, 2016
USD ($)
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Fair Value, Assets Measured on Recurring Basis, Unobservable Input Reconciliation, Calculation [Roll Forward] | |
Beginning of period | $ 1,485 |
Fair value decrease recorded in other comprehensive loss | (371) |
Fair value transferred to Level 2 | (1,114) |
Ending of period | $ 0 |
The Business and Summary of Significant Accounting Policies (Schedule of Prepaid and Other Current Assets) (Details) - USD ($) $ in Thousands |
Dec. 31, 2017 |
Dec. 31, 2016 |
---|---|---|
Accounting Policies [Abstract] | ||
Prepaid research and development expenses | $ 1,138 | $ 843 |
Interest receivable | 601 | 772 |
Prepaid insurance | 481 | 389 |
Other prepaid expenses and current assets | 1,111 | 841 |
Total prepaid expenses and other current assets | $ 3,331 | $ 2,845 |
The Business and Summary of Significant Accounting Policies (Schedule of Accrued Liabilities) (Details) - USD ($) $ in Thousands |
Dec. 31, 2017 |
Dec. 31, 2016 |
---|---|---|
Accounting Policies [Abstract] | ||
Accrued compensation | $ 3,678 | $ 2,906 |
Accrued research and development expenses | 3,384 | 2,257 |
Accrued indemnification claim | 1,000 | 0 |
Other accrued liabilities | 1,322 | 1,052 |
Total accrued liabilities | $ 9,384 | $ 6,215 |
Investments - Summary of Available-for-Sale Securities (Details) - USD ($) $ in Thousands |
Dec. 31, 2017 |
Dec. 31, 2016 |
---|---|---|
Schedule of Investments [Line Items] | ||
Amortized Cost | $ 210,666 | $ 228,405 |
Gross Unrealized Gains | 0 | 20 |
Gross Unrealized Losses | (963) | (460) |
Estimated Fair Value | 209,703 | 227,965 |
Certificates of deposit | ||
Schedule of Investments [Line Items] | ||
Amortized Cost | 7,445 | |
Gross Unrealized Gains | 5 | |
Gross Unrealized Losses | 0 | |
Estimated Fair Value | 7,450 | |
U.S. Treasury securities | ||
Schedule of Investments [Line Items] | ||
Amortized Cost | 210,280 | 219,415 |
Gross Unrealized Gains | 0 | 15 |
Gross Unrealized Losses | (963) | (201) |
Estimated Fair Value | 209,317 | 219,229 |
Common Stock | ||
Schedule of Investments [Line Items] | ||
Amortized Cost | 386 | 1,545 |
Gross Unrealized Gains | 0 | 0 |
Gross Unrealized Losses | 0 | (259) |
Estimated Fair Value | $ 386 | $ 1,286 |
Investments - Available for Sale Securities (Details) - USD ($) $ in Thousands |
Dec. 31, 2017 |
Dec. 31, 2016 |
---|---|---|
Schedule of Investments [Line Items] | ||
Maturing in one year or less | $ 132,586 | |
Maturing after one year through two years | 76,731 | |
Total debt investments | 209,317 | |
Total investments | 209,703 | $ 227,965 |
Common Stock | ||
Schedule of Investments [Line Items] | ||
Total investments | $ 386 | $ 1,286 |
Property and Equipment (Details) - USD ($) $ in Thousands |
Dec. 31, 2017 |
Dec. 31, 2016 |
---|---|---|
Property, Plant and Equipment [Line Items] | ||
Property and equipment, gross | $ 5,738 | $ 5,837 |
Less accumulated depreciation | (3,844) | (2,994) |
Property and equipment, net of accumulated depreciation | 1,894 | 2,843 |
Lab equipment | ||
Property, Plant and Equipment [Line Items] | ||
Property and equipment, gross | 2,496 | 2,419 |
Leasehold improvements | ||
Property, Plant and Equipment [Line Items] | ||
Property and equipment, gross | 1,552 | 1,570 |
Computer equipment | ||
Property, Plant and Equipment [Line Items] | ||
Property and equipment, gross | 1,170 | 1,262 |
Office furniture and equipment | ||
Property, Plant and Equipment [Line Items] | ||
Property and equipment, gross | $ 520 | $ 586 |
Loan Payable (Narrative) (Details) - USD ($) |
Jan. 27, 2012 |
Dec. 31, 2016 |
---|---|---|
Line of Credit Facility [Line Items] | ||
Loan and security agreement, maximum capacity | $ 15,000,000.0 | |
Loans payable, current | $ 0 | |
First tranche | ||
Line of Credit Facility [Line Items] | ||
Loan and security agreement, maximum capacity | $ 3,000,000.0 | |
Interest only period | 12 months | |
Principal and interest amortization period | 30 months | |
Loan and security agreement, interest rate | 8.25% | |
Second tranche | ||
Line of Credit Facility [Line Items] | ||
Loan and security agreement, maximum capacity | $ 12,000,000.0 | |
Interest only period | 6 months | |
Principal and interest amortization period | 32 months | |
Loan and security agreement, interest rate | 8.25% |
Commitments and Contingencies (Schedule of Future Minimum Rental Payments for Operating Leases) (Details) $ in Thousands |
Dec. 31, 2017
USD ($)
|
---|---|
Operating Leases, Future Minimum Payments Due, Fiscal Year Maturity [Abstract] | |
Minimum Rental Payment, 2018 | $ 735 |
Minimum Rental Payment, 2019 | 711 |
Minimum Rental Payment, 2020 | 720 |
Minimum Rental Payment, 2021 | 182 |
Total future minimum rental payments | $ 2,348 |
Commitments and Contingencies (Narrative) (Details) |
12 Months Ended | ||
---|---|---|---|
Dec. 31, 2017
USD ($)
ft²
|
Dec. 31, 2016
USD ($)
|
Dec. 31, 2015
USD ($)
|
|
Commitments and Contingencies Disclosure [Abstract] | |||
Operating leases, rent expense | $ 500,000 | $ 700,000 | $ 600,000 |
Area of sublease property (in sqft) | ft² | 3,537 | ||
Provision for refundable amounts under agreements | $ 0 | 0 | |
Accrued indemnification claim | $ 1,000,000 | $ 0 |
Commitments and Contingencies (Schedule of Future Minimum Sublease Rental Payments for Operating Leases) (Details) (Details) $ in Thousands |
Dec. 31, 2017
USD ($)
|
---|---|
Operating Leases, Future Minimum Payments Due, Fiscal Year Maturity [Abstract] | |
Minimum Sublease Rental Payment, 2018 | $ 75 |
Minimum Sublease Rental Payment, 2019 | 78 |
Minimum Sublease Rental Payment, 2020 | 81 |
Minimum Sublease Rental Payment, 2021 | 14 |
Total future minimum sublease rental payments | $ 248 |
Stockholders' Equity (Deficit) (Assumption Used to Determine the Fair Value of Options Granted) (Details) - $ / shares |
12 Months Ended | ||
---|---|---|---|
Dec. 31, 2017 |
Dec. 31, 2016 |
Dec. 31, 2015 |
|
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||
Weighted-average fair value per option (in USD per share) | $ 3.71 | $ 5.62 | $ 25.18 |
Employee stock option | |||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||
Expected volatility | 85.51% | 85.16% | 66.89% |
Expected term (in years) | 5 years 329 days | 6 years | 6 years |
Weighted-average risk-free interest rate | 2.02% | 1.70% | 1.53% |
Expected dividend yield | 0.00% | 0.00% | 0.00% |
Weighted-average fair value per option (in USD per share) | $ 3.71 | $ 5.62 | $ 25.18 |
Stockholders' Equity (Deficit) (Schedule of other information regarding stock options) (Details) - USD ($) $ / shares in Units, $ in Thousands |
12 Months Ended | ||
---|---|---|---|
Dec. 31, 2017 |
Dec. 31, 2016 |
Dec. 31, 2015 |
|
Stockholders' Equity Note [Abstract] | |||
Weighted-average fair value per option (in USD per share) | $ 3.71 | $ 5.62 | $ 25.18 |
Total intrinsic value of options exercised | $ 48 | $ 119 | $ 10,139 |
Total fair value of shares vested | $ 11,786 | $ 13,330 | $ 11,498 |
Stockholders' Equity (Deficit) (Schedule of Share-Based Compensation) (Details) - $ / shares |
12 Months Ended | ||
---|---|---|---|
Dec. 31, 2017 |
Dec. 31, 2016 |
Dec. 31, 2015 |
|
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||
Weighted-average fair value per option (in USD per share), ESPP purchase rights | $ 3.71 | $ 5.62 | $ 25.18 |
The 2013 Employee Stock Purchase Plan | |||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||
Expected volatility, ESPP purchase rights | 77.18% | 111.57% | 57.77% |
Expected term (in years), ESPP purchase rights | 355 days | 1 year 135 days | 1 year 1 month 24 days |
Weighted-average risk-free interest rate, ESPP purchase rights | 0.99% | 0.75% | 0.43% |
Expected dividend yield, ESPP purchase rights | 0.00% | 0.00% | 0.00% |
Weighted-average fair value per option (in USD per share), ESPP purchase rights | $ 2.65 | $ 3.20 | $ 22.10 |
Stockholders' Equity (Deficit) (Summary of Activity Related to Restricted Stock Units) (Details) - Restricted stock units (RSUs) |
12 Months Ended |
---|---|
Dec. 31, 2017
$ / shares
shares
| |
Number of Restricted Stock Units Outstanding | |
Beginning Balance (in shares) | shares | 946,200 |
Granted (in shares) | shares | 879,300 |
Shares issuance (in shares) | shares | (744,450) |
Forfeited (in shares) | shares | (124,751) |
Ending Balance (in shares) | shares | 956,299 |
Weighted-Average Grant-Date Fair Value | |
Beginning Balance (in USD per share) | $ / shares | $ 4.91 |
Granted (in USD per share) | $ / shares | 5.12 |
Shares issuance (in USD per share) | $ / shares | 4.91 |
Forfeited (in USD per share) | $ / shares | 5.09 |
Ending Balance (in USD per share) | $ / shares | $ 5.08 |
Stockholders' Equity (Deficit) (Schedule of Allocation of Recognized Period Costs) (Details) - USD ($) $ in Thousands |
12 Months Ended | ||
---|---|---|---|
Dec. 31, 2017 |
Dec. 31, 2016 |
Dec. 31, 2015 |
|
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||
Allocated share-based compensation expense | $ 16,110 | $ 16,223 | $ 12,959 |
Research and development expense | |||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||
Allocated share-based compensation expense | 7,047 | 7,137 | 5,578 |
General and administrative expense | |||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||
Allocated share-based compensation expense | $ 9,063 | $ 9,086 | $ 7,381 |
Income Taxes (Narrative) (Details) - USD ($) |
12 Months Ended | 93 Months Ended | ||||
---|---|---|---|---|---|---|
Dec. 31, 2017 |
Dec. 31, 2016 |
Dec. 31, 2015 |
Dec. 31, 2007 |
Dec. 31, 2002 |
Sep. 30, 2015 |
|
Operating Loss Carryforwards [Line Items] | ||||||
Income tax expense (benefit) | $ 0 | $ 0 | $ 0 | |||
Undistributed earnings of foreign subsidiary | 0 | |||||
Loss limitation ownership change benchmark amount | $ 762,000 | $ 64,000 | ||||
Annual limitation of operating loss carryforwards | $ 6,700,000 | |||||
Penalties and interest accrued | 0 | |||||
Effect of change in federal tax rate | 57,950,000 | 0 | $ 0 | |||
Domestic tax authority | ||||||
Operating Loss Carryforwards [Line Items] | ||||||
Operating loss carryforwards | 408,100,000 | 356,100,000 | ||||
Tax credit carryforward | 16,600,000 | |||||
State and local jurisdiction | ||||||
Operating Loss Carryforwards [Line Items] | ||||||
Operating loss carryforwards | 319,900,000 | $ 287,200,000 | ||||
Foreign tax authority | ||||||
Operating Loss Carryforwards [Line Items] | ||||||
Operating loss carryforwards | $ 400,000 |
Income Taxes (Components of Deferred Tax Assets and Liabilities) (Details) - USD ($) $ in Thousands |
Dec. 31, 2017 |
Dec. 31, 2016 |
---|---|---|
Deferred tax assets: | ||
Domestic net operating loss carryforwards | $ 92,020 | $ 114,111 |
Foreign net operating loss carryforwards | 61 | 0 |
Research and development expenses | 763 | 813 |
Capitalized Section 174 expenses | 28 | 48 |
Research and development credits | 12,437 | 10,907 |
Accrued bonuses | 777 | 1,006 |
Share-based compensation | 6,156 | 7,214 |
Other | 983 | 460 |
Total gross deferred tax assets | 113,225 | 134,559 |
Valuation allowance | (113,225) | (134,496) |
Total deferred tax assets | 0 | 63 |
Deferred tax liabilities: | ||
Other | 0 | (63) |
Total deferred tax liabilities | 0 | (63) |
Total deferred tax assets and liabilities, net | $ 0 | $ 0 |
Income Taxes (Summary of Uncertain Tax Benefit) (Details) - USD ($) $ in Thousands |
12 Months Ended | |
---|---|---|
Dec. 31, 2017 |
Dec. 31, 2016 |
|
Reconciliation of Unrecognized Tax Benefits, Excluding Amounts Pertaining to Examined Tax Returns [Roll Forward] | ||
Beginning balance | $ 2,400 | $ 1,956 |
Increase related to current year tax positions | 403 | 444 |
Increase related to prior periods | 473 | 0 |
Ending balance | $ 3,276 | $ 2,400 |
Selected Quarterly Financial Data (Unaudited) (Details) - USD ($) $ / shares in Units, $ in Thousands |
3 Months Ended | 12 Months Ended | |||||||||
---|---|---|---|---|---|---|---|---|---|---|---|
Dec. 31, 2017 |
Sep. 30, 2017 |
Jun. 30, 2017 |
Mar. 31, 2017 |
Dec. 31, 2016 |
Sep. 30, 2016 |
Jun. 30, 2016 |
Mar. 31, 2016 |
Dec. 31, 2017 |
Dec. 31, 2016 |
Dec. 31, 2015 |
|
Selected Quarterly Financial Information [Abstract] | |||||||||||
Total revenues | $ 1,844 | $ 897 | $ 675 | $ 1,078 | $ 1,980 | $ 653 | $ 1,841 | $ 1,228 | $ 4,494 | $ 5,702 | $ 10,762 |
Operating loss | (18,687) | (17,910) | (17,245) | (18,260) | (15,373) | (17,422) | (18,525) | (26,632) | (72,102) | (77,952) | (118,251) |
Net loss | $ (19,238) | $ (17,312) | $ (16,680) | $ (17,754) | $ (14,957) | $ (17,025) | $ (18,148) | $ (26,260) | $ (70,984) | $ (76,390) | $ (117,372) |
Net loss per share, basic and diluted (in USD per share) | $ (0.41) | $ (0.37) | $ (0.36) | $ (0.38) | $ (0.32) | $ (0.37) | $ (0.39) | $ (0.57) | $ (1.51) | $ (1.65) | $ (2.67) |
Weighted-average shares outstanding, basic and diluted (in shares) | 47,341,271 | 47,065,756 | 46,863,753 | 46,573,394 | 46,431,809 | 46,236,749 | 46,214,086 | 46,184,134 | 46,963,430 | 46,267,064 | 43,878,326 |
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